BD Luer-Lok 309572Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00382903095728), received between Dec 20, 2017 and Sep 10, 2025 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (8 reports).

10 other recalls cover devices cleared under the same FDA submission (K110771); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 22X1 RB HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309572, LOT#: 1169514. RCC RECEIVED A COMPLAINT VIA EMAIL. A SYRINGE DEFECT WAS BROUGHT TO MY ATTENTION YESTERDAY AFTERNOON: XXX WAS TO BE INJECTED WITH MEDICATION ON (B)(6) 2025. THE NURSE INJECTED THE NEEDLE INTO RIGHT UPPER ARM AND AS MEDICATION WAS PUSHED THROUGH THE SYRINGE, THE ENTIRE SYRINGE CAME APART FROM THE NEEDLE. THE MEDICATION SHOT OUT FROM THE SYRINGE AND SPLASHED STAFF AND THE RESIDENT. NO ONE WAS INJURED/HARMED DURING THIS INCIDENT. SAMPLE IS NOT AVAILABLE, AS IT NEEDED TO BE DISPOSED OF PROPERLY. PICTURES OF PACKAGE WRAPPER AND DEFECTIVE SYRINGE ATTACHED FOR REFERENCE. PRODUCT NAME/CATALOG NUMBER- BD PLASTIPAK 3ML SYRINGE, LUER-LOK TIP WITH PRECISION GLIDE NEEDLE, 22G X 1¿, #309572, (B)(4), LOT#: 1169514, EXPIRATION DATE: 5/31/2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015623 ↗
• MalfunctionFeb 20, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD LUER-LOK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A CLIENT OF OURS HAS RECEIVED PRODUCT WITH A WHITE FILM COATING ON IT." ITEM # 309572. LOT ¿ 2168983. EXP ¿ 05/31/2027. ADDITIONAL INFORMATION RECEIVED BY CUSTOMER ON 02/16/2024: "THE WHITE FILM WAS ON THE NEEDLE. SEE THE ATTACHED IMAGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18742226 ↗
• InjurySep 14, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE EXPERIENCED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER INJECTED AS NORMAL. EXTENSIVE SORENESS AFTER A PROLONGED PERIOD IN THE INJECTION AREA. UNSCREWED THE NEEDLE FROM THE HUB TO INSPECT- FOUND BROWN FOREIGN MATTER CONTAMINANT. CUSTOMER MENTIONED ADDITIONAL PHYSICAL AND NEUROLOGICAL SYMPTOMS, BUT DID NOT DIRECTLY BLAME THE INJECTION. A VISIT TO THE HOSPITAL IS SCHEDULED. HAS THE SAMPLE AND WILL SEND IT IN IF PROVIDED LABELS. ADD INFO RECEIVED: 1ST CUSTOMER RESPONSE COULD YOU KINDLY PROVIDE THE ADDRESS FOR US TO CREATE A RETURN LABEL? (B)(6). COULD YOU PROVIDE THE PHOTO/VIDEO OF THE REPORTED ISSUE? PLEASE SEE PHOTOS. WHERE WAS THE FOREIGN MATTER (FM) LOCATED? IT WAS LOCATED IN THE TIP OF THE SYRINGE AND THE NEEDLE PLASTIC BASE. IN THE FLUID PATH? THE CONTAMINANT WAS IN THE FLUID PATH. IS THE FM ABLE TO BE REMOVED OR IS IT EMBEDDED IN THE PLASTIC / NEEDLE? THE FM IS ABLE TO BE REMOVED. WHAT IS THE PATIENT OUTCOME? ARE THERE ANY ADVERSE EVENTS/SERIOUS INJURIES? I AM STILL EXPERIENCING PAIN AND INFLAMMATION AT AND AROUND THE INJECTION SITE. WAS THERE ANY MEDICAL INTERVENTION INVOLVED TO TREAT TH

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 17750003 ↗
• MalfunctionAug 31, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I JUST OPENED & UNCAPPED A SYRINGE + NEEDLE, AND I SEE THE NEEDLE IS COVERED WITH PARTICLES OF SOME KIND. PRIOR TO OPENING IT, IT WAS STORED IN ITS SEALED WRAPPER IN THE BAG I RECEIVED IT IN FROM THE PHARMACY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666271 ↗
• MalfunctionDec 1, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH THE BD PRECISIONGLIDE¿ NEEDLE WAS BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE USED 7 NEEDLES OUT OF THIS BATCH. THE ONE I USED TONIGHT I NEEDED TO USE ALL MY POWER TO PUSH DOWN. I COULDN'T GIVE HIM THE REST OF THE NEEDED MEDICINE BECAUSE IT WOULDN'T MOVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15899857 ↗
• MalfunctionNov 29, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD SYRINGE 3ML LL W/NDL 22X1 RB FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: DIRT ON NEEDLE AND IN THE SYRINGE. ADDITIONAL INFORMATION RECEIVED 10-NOV-2022. DO YOU KNOW THE DATE OF EVENT? (B)(6) 2022. DO YOU KNOW THE QTY OF PRODUCT THAT ACTUALLY HAD THE DIRT ON THE NEEDLE AND INSIDE THE SYRINGE? ONE. WAS THERE ANY USE ON PATIENTS? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15883452 ↗
• MalfunctionNov 15, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD LUER-LOK¿ SYRINGES WITH THE BD PRECISIONGLIDE¿ NEEDLE HAD ISSUES CONNECTING TO THE SYRINGE DURING USE AND LEAKED MEDICATION AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OTHERS WOULD NOT SEAL CORRECTLY WHERE NEEDLE IS THREADED TO SYRINGE CAUSING DIFFICULTY DRAWING MEDS AND LOSING MEDS WHEN ADMINISTERING (SO NOT KNOWING IF PROPER DOSE WAS RECEIVED)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15800081 ↗
• MalfunctionOct 25, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL 22X1 RB HAD LIQUID INSIDE. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SYRINGES HAD A LIQUID IN THEM BEFORE DRAWING UP MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12689684 ↗
• MalfunctionAug 11, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE STOPPER IN THE BD LUER-LOK¿ SYRINGE WITH THE BD PRECISIONGLIDE¿ NEEDLE WAS LOOSE AND DID NOT PROVIDE AN ADEQUATE SEAL, CAUSING ONE DOSE TO LEAK OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD SEVERAL SYRINGES THAT HAVE NOT HAD AN ADEQUATE SEAL. THIS HAS CAUSED ISSUES DRAWING PATIENT DOSES, AS WELL AS ADMINISTERING PATIENT DOSES. ONE OF OUR END USERS REPORTED THAT THE DOSE LEAKED OUT OF THE SYRINGE DUE TO IMPROPER SEAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12308154 ↗
• MalfunctionAug 10, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL 22X1 RB HAD AN IMPROPER SEAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SEVERAL SYRINGES THAT HAVE NOT HAD AN ADEQUATE SEAL. VERBATIM: WE HAVE HAD SEVERAL SYRINGES THAT HAVE NOT HAD AN ADEQUATE SEAL. THIS HAS CAUSED ISSUES DRAWING PATIENT DOSES, AS WELL AS ADMINISTERING PATIENT DOSES. ONE OF OUR END USERS REPORTED THAT THE DOSE LEAKED OUT OF THE SYRINGE DUE TO IMPROPER SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12302862 ↗
• MalfunctionAug 10, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL 22X1 RB HAD AN IMPROPER SEAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SEVERAL SYRINGES THAT HAVE NOT HAD AN ADEQUATE SEAL. VERBATIM: WE HAVE HAD SEVERAL SYRINGES THAT HAVE NOT HAD AN ADEQUATE SEAL. THIS HAS CAUSED ISSUES DRAWING PATIENT DOSES, AS WELL AS ADMINISTERING PATIENT DOSES. ONE OF OUR END USERS REPORTED THAT THE DOSE LEAKED OUT OF THE SYRINGE DUE TO IMPROPER SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12302789 ↗
• MalfunctionFeb 5, 2021Break; Break

  IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL 22X1 RB NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309572 BATCH NO: UNKNOWN (PROVIDED 0208010) IT WAS REPORTED NEEDLE BROKE ON THE SITE . VERBATIM: CONSUMER REPORTED - REMOVED THE NEEDLE FROM SITE AFTER INJECTION WITH TESTOSTERONE, AND THE NEEDLE WAS MISSING. NOT FOUND ON THE FLOOR. CONSUMER REPORTED - WENT TO FIRST DOCTORS VISIT (B)(6) 2021 FOR A CONSULT FOR THIS INCIDENT. DOCTOR LOOKED AT THIS SITE THAT HE CIRCLED WITH INK. THEY WILL COMPLETE AN XRAY ON (B)(6) /2021 OF THE SITE MARKED PLUS A CYSTS THAT HE HAS HAD BEFORE THIS INCIDENT. DATE OF EVENT: (B)(6) 2021. SAMPLES STATUS - DISCARDED ONE IN QUESTION. SENDING MAILING KIT FOR UNUSED SAMPLES. FROM PHONE CALL ON (B)(6) 2021 09:50:21: CALLED AND LEFT A VOICE MESSAGE ON THIS CONSUMERS VOICE MAIL. CONSUMER DID NOT REPLY TO THE EMAIL THAT I SENT TO OBTAIN THE ITEM AND LOT NUMBER AS REQUESTED. DC PER UPDATE IN SNOW BY US COM ADDED ON ON (B)(6) 2021. FROM PHONE CALL ON 2021-01-15 14:55:12: CALLED THIS CONSUMER. HE IS CURRENTLY NOT AT HOME AGAIN. UPDATED THIS CASE WITH CONSUMER ADDRESS. CONSUMER INFORMED HE WAS TAKING HIS TESTOSTERONE INJECTION ON

  Patient problems: Foreign Body In Patient

  MAUDE report 11285827 ↗
• MalfunctionJan 4, 2021Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL 22X1 RB HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309572 BATCH ,NO.: 0071482. IT WAS REPORTED THAT 4 SYRINGES WERE MISSING 1 EMPTY SEALED BAG, AND SCALE PRINTING IS POOR. CUSTOMER RESPONSE: THE VETERINARY PRACTICES HAS INFORMED OUR QUEBEC CONTACT THAT THE LOT AND EXPIRY DATE IS THE SAME AS THE ONE IN MY EMAIL. WE HAVE ASKED THEM TO PUT THE REMAINING 2 BOXES ASIDE. PER EMAIL: WE HAVE A CUSTOMER THAT IS REPORTING ISSUES WITH YOUR BD 3ML 22GX1'' PRODUCT. THEY HAVE INDICATED THAT OUT OF THE BOX OF 100 UNITS, 4 SYRINGES WERE MISSING.

  Patient problems: No Patient Involvement

  MAUDE report 11108356 ↗
• MalfunctionSep 24, 2020Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT 74 BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLES EXPERIENCED MISSING SCALE MARKINGS AND SCALE MARKING ISSUES WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION DATE RECEIVED FOR INTAKE: (B)(6) 2020. MATERIAL NO: 309572, BATCH NO: 0065936. DURING PRODUCTION SET UP ON (B)(6) 2020, SEVERAL 3 ML BD SYRINGES WERE FOUND TO HAVE NO MARKINGS TO INDICATE VOLUME. A TECHNICIAN WENT THROUGH ALL SYRINGES FROM THIS LOT ON SITE, AND FOUND, OUT OF APPROXIMATELY 800, THERE WERE 74 WITHOUT THE NECESSARY MARKINGS. ANOTHER TECHNICIAN SAID THAT THEY HAD ALSO ENCOUNTERED ONE OF THESE SYRINGES EARLIER THAT DAY.

  Patient problems: No Patient Involvement

  MAUDE report 10578318 ↗
• MalfunctionJun 2, 2020Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BOX OF BD SYRINGES WITH LUER-LOK¿ TIP AND BD PRECISIONGLIDE¿ NEEDLE HAD NO EXPIRATION DATE ON IT BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST CALLED TO INQUIRE ABOUT EXPIRATION AND DISPOSAL OF EXPIRED SYRINGES. LOT #S 3298116, 4154804, 0054508, 2150297 AND 3212011. PHARMACIST SAID THERE IS NO EXPIRATION DATE ON THE BOXES."

  Patient problems: No Patient Involvement

  MAUDE report 10112264 ↗
• MalfunctionDec 2, 2019Fungus in Device Environment; Fungus in Device Environment

  IT WAS REPORTED THAT BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE HAD MOLD ON IT. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309572 BATCH NO. 9203066 IT WAS REPORTED THAT MOLD WAS NOTICED ON LUER LOK SYRINGES WHEN DISPENSING THE SYRINGES TO A CONSUMER. PHARMACIST CALLED TO REPORT MOLD ON LUER LOK SYRINGES (1) FULL BOX OF INDIVIDUALLY WRAPPED SYRINGES. STATED THAT SHE WAS DISPENSING THE SYRINGES TO A CONSUMER WHEN SHE NOTICED THE MOLD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9395517 ↗
• MalfunctionJul 30, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BROWN FOREIGN MATTER WAS FOUND INSIDE THE BD SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE BEFORE USE DURING A VISUAL INSPECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING COMPONENT CHECK-IN, THE SITE NOTICED ONE OF THE SYRINGES HAD A BROWN FOREIGN SUBSTANCE PRESENT INSIDE THE SYRINGE. THE OTHER SYRINGES PASSED THE VISUAL INSPECTION TEST."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8842356 ↗
• MalfunctionApr 4, 2019Crack

  IT WAS REPORTED THAT THE BD SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE HAD A CRACKED BARREL THAT WAS NOTICED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISTRIBUTOR CALLED TO REPORT THAT CUSTOMER HAS FOUND A COUPLE OF SYRINGES WITH CRACKS IN THE BARRELS. STATED THAT THE CUSTOMER WAS UNSURE OF WITH LOT NUMBER IT CAME FROM, EITHER 9008974 OR 8300795"

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8484919 ↗
• MalfunctionMar 29, 2019Leak/Splash

  IT WAS REPORTED THAT BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿MATERIAL NO.: 309572 BATCH NO.: 8300796. IT WAS REPORTED THE CONTENTS LEAKED OUT OF THE BARREL PAST THE STOPPER. PER EMAIL: (LOT 8300796 FIVE INSTANCES BETWEEN THE TWO HOSPITALS THEY DIDN¿T BREAK IT DOWN FURTHER) PER 1213809-2019-00387 - 1 PETNET DETROIT & HOUSTON. CUSTOMER COMPLAINT RECEIVED FROM TWO HOSPITALS REGARDING A LOOSE PLUNGER WHICH CAUSED LEAKING OF CONTENTS. SPECIFICALLY, ONE INSTANCE WITH LOT# 8300798 (EXPIRY 10/31/2023) WHERE THE PLUNGER PULLED OUT OF THE CYLINDER TOO EASILY AND THE SYRINGE CONTENTS WERE LOST. THERE WERE ALSO MULTIPLE INSTANCES WITH THIS LOT WHERE THE NEEDLE CAPS WERE NOTICEABLY LOOSER THAN PRIOR LOTS (THE CAPS STAYED ATTACHED, BUT NO NOTICEABLE CLICK WHEN CLOSING). FIVE INSTANCES WITH LOT# 8300796 (EXPIRY 09/30/2023) WHERE THE LIQUID WAS ESCAPING THE BARREL THROUGH THE PLUNGER SEAL."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8464106 ↗
• MalfunctionMar 15, 2019Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT A BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE HAD LEAKAGE. THE FOLLOWING WAS REPORTED, " WAS REPORTED THE PLUNGER PULLED OUT OF THE SYRINGE BARREL TOO EASILY AND THE CONTENTS LEAKED OUT. IT WAS ALSO REPORTED THE NEEDLE CAPS WERE NOTICEABLY LOOSE AND WOULD NOT CLICK WHEN CLOSING. CUSTOMER COMPLAINT RECEIVED FROM TWO HOSPITALS REGARDING A LOOSE PLUNGER WHICH CAUSED LEAKING OF CONTENTS. SPECIFICALLY, ONE INSTANCE WITH LOT# 8300798 (EXPIRY 10/31/2023) WHERE THE PLUNGER PULLED OUT OF THE CYLINDER TOO EASILY AND THE SYRINGE CONTENTS WERE LOST. THERE WERE ALSO MULTIPLE INSTANCES WITH THIS LOT WHERE THE NEEDLE CAPS WERE NOTICEABLY LOOSER THAN PRIOR LOTS (THE CAPS STAYED ATTACHED, BUT NO NOTICEABLE CLICK WHEN CLOSING) FIVE INSTANCES WITH LOT# 8300796 (EXPIRY 09/30/2023) WHERE THE LIQUID WAS ESCAPING THE BARREL THROUGH THE PLUNGER SEAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8426107 ↗
• MalfunctionMar 13, 2019Fluid/Blood Leak

  IT WAS REPORTED THAT BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE LEAKED FROM THE BARREL THROUGH THE PLUNGER SEAL. THIS OCCURRED ON 5 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDIAL INTERVENTION WAS REPORTED. VERBATIM: "MATERIAL NO.: 309572 BATCH NO.: 8300796. IT WAS REPORTED THE LIQUID ESCAPED THE BARREL THROUGH THE PLUNGER SEAL PER (B)(4). PETNET DETROIT & HOUSTON. CUSTOMER COMPLAINT RECEIVED FROM TWO HOSPITALS REGARDING A LOOSE PLUNGER WHICH CAUSED LEAKING OF CONTENTS. SPECIFICALLY, ONE INSTANCE WITH LOT# 8300798 (EXPIRY 10/31/2023) WHERE THE PLUNGER PULLED OUT OF THE CYLINDER TOO EASILY AND THE SYRINGE CONTENTS WERE LOST. THERE WERE ALSO MULTIPLE INSTANCES WITH THIS LOT WHERE THE NEEDLE CAPS WERE NOTICEABLY LOOSER THAN PRIOR LOTS (THE CAPS STAYED ATTACHED, BUT NO NOTICEABLE CLICK WHEN CLOSING) FIVE INSTANCES WITH LOT# 8300796 (EXPIRY 09/30/2023) WHERE THE LIQUID WAS ESCAPING THE BARREL THROUGH THE PLUNGER SEAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8416997 ↗
• MalfunctionJan 24, 2019Gas/Air Leak

  IT WAS REPORTED THAT A BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ WILL NOT DRAW BLOOD CORRECTLY, AND DOES NOT HAVE GOOD CLOSURE, JUST AIR BUBBLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8276006 ↗
• MalfunctionOct 31, 2018Leak/Splash; Material Separation

  IT WAS REPORTED WITH THE USE OF THE BD LUER LOK¿ SYRINGE WITH NEEDLE THERE WAS AN ISSUE WITH HUB SEPARATING CAUSING LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8023915 ↗
• MalfunctionAug 6, 2018Leak/Splash

  IT WAS REPORTED THAT BD LUER LOK¿ SYRINGE WITH NEEDLE HAD LEAKAGE "BEYOND THE STOPPER". NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7751966 ↗
• MalfunctionJul 22, 2018Leak/Splash

  IT WAS REPORTED THAT THE BD LUER LOK¿ SYRINGES WITH NEEDLES WERE LEAKING WHEN FILLED. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7709450 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110771. One submission often covers many models, so check the product and lot details in each record.

• Z-2614-2026 · Apr 28, 2026 · Open, Classified
  SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
• Z-2751-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-2752-2017 · Sep 16, 2016 · Terminated
  BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injec
• Z-2750-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syringe is intended for use by health care prof
• Z-2753-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-2747-2017 · Sep 16, 2016 · Terminated
  BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
• Z-2749-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x 25mm) Catalog #309571 The BD Single Use, Hypodermic Syringe is intended for use by health care professi
• Z-1936-2016 · Mar 25, 2016 · Terminated
  Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-1937-2016 · Mar 25, 2016 · Terminated
  Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-1055-2015 · Dec 19, 2014 · Terminated
  BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 4