N/A 309658Recalls & reported problems

Summary

The FDA's MAUDE database contains 189 adverse event reports that list this exact device (DI 00382903096589), received between Oct 23, 2017 and Sep 28, 2026 — classified as 4 injuries, 185 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (49 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 189 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918110 ↗
• MalfunctionJun 18, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE 3ML LL EURO 200 S/C CONTAINED FOREIGN MATTER. MATERIAL: 309658 BATCH: 5342377 PLASTIC PARTICLES ARE FOUND ON THE RUBBER OF THE PLUNGER WHEN THE SYRINGES ARE USED. IMAGES OF THE DEFECT ARE ATTACHED. THE DEFECT WAS DISCOVERED DURING MOUNTING AND TAKEN OUT OF CIRCULATION. THUS, THERE WAS NO DANGER TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25551989 ↗
• MalfunctionApr 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD SYRINGE 3ML LL EURO 200 S/C CONTAINED FOREIGN MATTER. IT WAS REPORTED THAT ON THREE OCCASIONS, POST MANUFACTURE, WE HAVE DISCOVERED SMALL PARTICULATES IN THE INFUSION BAG. BD LUER-LOK PLASTIPAK 10ML SYRINGE. WHEN DID THE INCIDENT OCCUR? DURING USE. AS PART OF AN ONGOING CLINICAL TRIAL, WE CURRENTLY USE TWO OF YOUR PRODUCTS TO PREPARE INFUSION BAGS CONTAINING INVESTIGATIONAL MEDICINAL PRODUCTS. ON THREE OCCASIONS, POST MANUFACTURE, WE HAVE DISCOVERED SMALL PARTICULATES IN THE INFUSION BAG. AS PART OF AN ONGOING INVESTIGATION ON THE NATURE OF THESE PARTICLES, WE ARE SEEKING ANY INFORMATION FROM THE MANUFACTURERS OF THE ANCILLARY SUPPLIES, TO DETERMINE IF THERE ARE ANY REPORTS OF PARTICULATE CONTAMINATION IN THE BATCHES. THE INVESTIGATION IS ONGOING AND THE PARTICLE COMPOSITION HAS NOT YET BEEN TESTED ALTHOUGH THIS PROCESS IS UNDERWAY. ITEM: 309658. RESPONSE RECEIVED ON: (B)(6) 2026 12:54 PM. NOTE THAT THE CURRENT SUSPICION IS THAT THESE PARTICLES ARE SMALL PVC PARTICLES FROM THE BUNG IN THE INFUSION BAG. THE SPONSOR COMPANY WHO IS CONDUCTING THE CLINICAL TRIAL HAVE UPLIFTED THE CONTAMINATED INFUSION BAGS TO TEST THE CONTAMINANT. THE HAVE JUST ASKED ME TO NOTIF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791903 ↗
• MalfunctionApr 6, 2026Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791901 ↗
• MalfunctionMar 20, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE 3ML LL EURO 200 S/C CONTAINED FOREIGN MATTER. EMAIL ¿ COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. QUALITY RECEIVED A PRODUCT COMPLAINT FROM THE CONSUMER STATING THE PATIENT NOTICED THAT THERE WAS A BROWN SUBSTANCE DRIED ON THE INSIDE OF THE SYRINGE. THE DATE REPORTED IS 08-FEB-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650664 ↗
• MalfunctionMar 10, 2026Connection Problem

  IT WAS REPORTED THAT BD SYRINGE 3ML LL EURO 200 S/C HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. VERBATIM: WHEN DRAWING THE MEDICATION INTO THE SYRINGE, THE CONNECTION POINT BETWEEN THE SYRINGE AND NEEDLE LEAKS. UNFORTUNATELY, THE NEEDLE IN QUESTION HAS NOT BEEN SENT FOR COMPLAINT, ONLY THE SYRINGE. CUSTOMER SAID THAT THE EVENT DAY IS THE DAY THE PRODUCT COMPLAINT HAS SUBMITTED. NO HARM FOR PATIENT OR NURSE. CUSTOMER DOESNT KNOW, WHAT KIND OF LIQUID AND MEDICINE WAS INVOLVED, BUT THOSE WERE ORDINARY. NO TOXIC WERE USE. MAYBE PROPOFOLI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563579 ↗
• MalfunctionFeb 20, 2026Crack

  IT WAS REPORTED THAT BD SYRINGE 3ML LL EURO 200 S/C BARREL WAS CRACKED. VERBATIM: THE PREPARER, WHILE PREPARING A CHEMOTHERAPY BAG, USED A 3ML SYRINGE THAT WAS CRACKED. THUS, WHEN WITHDRAWING A VOLUME FROM THE BAG, THE CONTENTS SPILLED INTO THE ISOLATOR. THE SYRINGE WAS SET ASIDE TO BE GIVEN TO MATERIALS VIGILANCE. THIS INCIDENT WAS NOT SERIOUS BECAUSE NO CHEMOTHERAPY HAD YET BEEN ADDED TO THE BAG (NO CYTOTOXIC CONTAMINATION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24407901 ↗
• MalfunctionFeb 20, 2026Crack; Leak/Splash

  IT WAS REPORTED THAT BD SYRINGE 3ML LL EURO 200 S/C BARREL WAS CRACKED. "DURING THE PREPARATION OF CHEMOTHERAPIES IN THE INJECTABLE RECONSTITUTION UNIT AT THE PUI, WE NOTICED VISIBLE CRACKS ON 2 SYRINGES OF DIFFERENT SIZES AND LOTS. THIS COULD LEAD TO CYTOTOXIC CONTAMINATION OF THE WORKING ENVIRONMENT AND PERSONNEL (EVEN THOUGH THE RISK IS MINIMAL AS HANDLING OCCURS UNDER AN ISOLATOR) AND PRODUCT LOSS." THE CRACK WAS ALONG THE BODY OF THE SYRINGE FOR BOTH REFERENCES (B)(4). WHEN THE PERSON PUSHED THE PLUNGER, PRODUCT CAME OUT THROUGH THE CRACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406816 ↗
• MalfunctionFeb 19, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE 3ML LL EURO 200 S/C CONTAINED FOREIGN MATTER. IT WAS REPORTED THAT A CLINICAL TRIAL SITE HAS NOTED THAT THERE ARE BLACK BLEMISHES/SPOTS VISIBLE ON OR IN BD SYRINGES. THE QUALITY TEAM HAS COMPLETED A AQL2, AND WE HAVE FOUND FURTHER LOTS WITH IMPACT. PART NUMBER: LOT NO: 309628 , 5066461, 309628 , 4354445, 309628, 4354445, 309628 , 5101152, 309658 , 5281022, 309658 , 5072741, 309658, 4354445, 309658 , 4352796, 309658 , 4354445, 309658, 5072741.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24392246 ↗
• MalfunctionFeb 19, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE 3ML LL EURO 200 S/C CONTAINED FOREIGN MATTER. IT WAS REPORTED THAT A CLINICAL TRIAL SITE HAS NOTED THAT THERE ARE BLACK BLEMISHES/SPOTS VISIBLE ON OR IN BD SYRINGES. THE QUALITY TEAM HAS COMPLETED A AQL2, AND WE HAVE FOUND FURTHER LOTS WITH IMPACT. PART NUMBER, LOT NO; 309628, 5066461; 309628, 4354445; 309628, 4354445; 309628, 5101152; 309658, 5281022; 309658, 5072741; 309658, 4354445; 309658 4352796; 309658, 4354445; 309658, 5072741.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24392204 ↗
• MalfunctionFeb 19, 2026Contamination

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24392199 ↗
• MalfunctionFeb 17, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE 3ML LL EURO 200 S/C CONTAINED FOREIGN MATTER. A CLINICAL TRIAL SITE HAS NOTED THAT THERE ARE BLACK BLEMISHES/SPOTS VISIBLE ON OR IN BD SYRINGES. PLEASE SEE ATTACHED PICTURE EVIDENCE. CONFIRMED PRODUCTS AND LOT NUMBERS SO FAR THAT ARE CONFIRMED ARE BELOW: BD 1ML SYRINGES, LOT: 4354445, EXPIRY: 2029-11-30, BD 3ML SYRINGES, LOT: 4352796, EXPIRY: 2029-11-30, BD 3ML SYRINGES, LOT: 5072741, EXPIRY: 2030-02-28. OUT CLIENT NOTED THE BLEMISHES/ BLACK SPOTS ON (B)(6) 2026. FCS WERE INFORMED ON THE 26TH JANUARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367803 ↗
• MalfunctionFeb 17, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE 3ML LL EURO 200 S/C CONTAINED FOREIGN MATTER. A CLINICAL TRIAL SITE HAS NOTED THAT THERE ARE BLACK BLEMISHES/SPOTS VISIBLE ON OR IN BD SYRINGES. CONFIRMED PRODUCTS AND LOT NUMBERS SO FAR THAT ARE CONFIRMED ARE BELOW: BD 1ML SYRINGES: LOT: 4354445 EXPIRY: 2029-11-30. BD 3ML SYRINGES: LOT: 4352796 EXPIRY: 2029-11-30. BD 3ML SYRINGES: LOT: 5072741 EXPIRY: 2030-02-28. OUT CLIENT NOTED THE BLEMISHES/ BLACK SPOTS ON THE 9TH JANUARY 2026. FCS WERE INFORMED ON THE 26TH JANUARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367798 ↗
• MalfunctionDec 17, 2025Leak/Splash; Nonstandard Device; Leak/Splash; Nonstandard Device

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL EURO 200 S/C PLUNGER ROD WAS BROKEN / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT ON (B)(6) 2025, IN THE BLOOD DISEASES DEPARTMENT, BEFORE ADMINISTERING VIDAZA SYRINGES TO A PATIENT, AS THE NURSE WAS ROLLING THE SYRINGES BETWEEN HER HANDS TO WARM THEM UP, THE SYRINGE PLUNGER CAME LOOSE. THIS RESULTED IN THE LEAKAGE OF THE CYTOTOXIC PRODUCT FROM THE SYRINGE, CAUSING CHEMICAL CONTAMINATION OF THE ENVIRONMENT AND OCCUPATIONAL EXPOSURE. THIS IS THE SECOND INCIDENT IN TWO DAYS (SEE MV 9794). THERE WERE NO CONSEQUENCES FOR THE PATIENT OTHER THAN A DELAY IN TREATMENT. THE DEVICE INVOLVED IN THIS INCIDENT HAS NOT BEEN RETAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835177 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: Abscess

  MAUDE report 23815629 ↗
• MalfunctionDec 14, 2025Leak/Splash; Nonstandard Device; Leak/Splash; Nonstandard Device

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL EURO 200 S/C PLUNGER ROD WAS BROKEN / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REFERENCE: (B)(6). BATCH OR SERIAL NUMBER: NA EXPIRY DATE: UNKNOWN. ON (B)(6) 2025, IN THE BLOOD DISEASES DEPARTMENT, BEFORE ADMINISTERING VIDAZA SYRINGES TO A PATIENT, WHEN THE NURSE WAS ROLLING THE SYRINGES BETWEEN HIS HANDS TO WARM THEM UP, THE PLUNGER OF ONE OF THE TWO SYRINGES CAME LOOSE, RESULTING IN THE CYTOTOXIC PRODUCT LEAKAGE FROM THE SYRINGE, CAUSING CHEMICAL CONTAMINATION OF THE ENVIRONMENT AND OCCUPATIONAL EXPOSURE. THIS WAS AN ISOLATED INCIDENT. THERE WERE NO CONSEQUENCES FOR THE PATIENT OTHER THAN A DELAY IN TREATMENT. THE DEVICE INVOLVED IN THIS INCIDENT WAS NOT RETAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23799508 ↗
• InjuryNov 6, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL EURO 200 S/C HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DURING AN EYE SURGERY, THE NEEDLE CAME LOOSE DESPITE THE LUER-LOC CONNECTOR. THE PATIENT SUSTAINED AN EYE INJURY, RESULTING IN A LACERATION OF THE IRIS ROOT. ADDITIONAL INFORMATION PROVIDED: 1.) DURING CATARACT SURGERY, THE ANTERIOR CHAMBER WAS FLUSHED DUE TO BLEEDING. THE REMAINING SURGICAL STEPS WERE UNEVENTFUL ¿ DIAMOX 250MG WAS ADMINISTERED UPON DISCHARGE TO REDUCE INTRAOCULAR PRESSURE. 2.) CLOSE MONITORING WAS PERFORMED IN THE OUTPATIENT CLINIC. A BRIEF INCREASE IN INTRAOCULAR PRESSURE ON THE FIRST POST-OPERATIVE DAY WAS TREATED WITH DIAMOX AND COSOPT (TABLETS AND GTT, NO IV THERAPY NECESSARY). 3.) NO FURTHER MEDICATION WAS REQUIRED. THE PATIENT, WITH MILD CORNEAL EDEMA (POST-OPERATIVE), WAS REFERRED TO A SPECIALIST FOR FURTHER FOLLOW-UP. HER FINAL VISUAL ACUITY WAS 0.6.

  Patient problems: Eye Injury

  MAUDE report 23491624 ↗
• MalfunctionOct 20, 2025Crack; Crack

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL EURO 200 S/C BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CODE: SERINGE 3 PIECE LUER LOCK 03ML REFERENCE : 309658 BATCH NUMBER : NR EXPIRY DATE : NR MEDICAL DEVICE KEPT : NO NUMBER OF PRODUCT CONCERNED : 1 DATE OF EVENT : 25/09/2025 PLACE OF EVENT : PHARMACY (CYTOTOXIC RECONSTITUTION UNIT) ANSM DECLARATION: NO DESCRIPTION OF THE EVENT : THE 3 ML SYRINGE WHICH PUNCTURED/SPLIT DURING THE PREPARATION OF VIDAZA (IN THE ISOLATOR). THE CYTOTOXIC AGENT HAD TO BE DISCARDED, THE PREPARATION REDONE AND THE ISOLATOR CLEANED. CONSEQUENCE: LOSS OF THE VIAL OF VIDAZA, LOSS OF TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335256 ↗
• MalfunctionOct 15, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL EURO 200 S/C HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED THAT PATIENT IS ADMINISTERED AZACITIDINE AT HOME BY VPK FROM EXPERT CARE, WHEN ADMINISTERED THE CONNECTION OF THE NEEDLE TO THE SYRINGE LEAKED. ANOTHER NEEDLE WAS SET UP, BUT THERE WAS STILL SOME LEAKAGE. THE COMPLAINT MATERIAL HAS NOT BEEN PRESERVED. THIS NOTIFICATION IS THEREFORE ONLY INTENDED FOR YOUR RECORDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23295027 ↗
• MalfunctionOct 9, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL EURO 200 S/C PLUNGER ROD WAS BROKEN / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE PISTON PART BROKE WHILE DISPENSING SALINE SOLUTION. YOU CAN FIND THE PRODUCT PHOTO ATTACHED. WHEN DID THE INCIDENT OCCUR? DURING USE. NO ONE WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23260898 ↗
• MalfunctionAug 18, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL EURO 200 S/C HAD VISIBLE SILICONE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MULTIPLE SKU W/ VISIBLE PARTICLES, DEFECTIVE PLUNGERS, EXCESSIVE LUBRICANT. WHEN DID THE INCIDENT OCCUR? BEFORE USE PLEASE NOTE THAT WE HAVE IDENTIFIED SEVERAL QUALITY DEFECTS IN THE SYRINGES RECEIVED UNDER (B)(4). THE ISSUES OBSERVED INCLUDE: ¿ VISIBLE PARTICLES INSIDE THE SYRINGE ¿ PARTICLES BETWEEN THE PLUNGER AND BARREL SPACE ¿ MULTIPLE WHITE PARTICLES FOUND INSIDE THE PACKAGING ¿ DEFECTIVE PLUNGERS ¿ EXCESSIVE LUBRICANT THE DETAILS OF THE REJECTED ITEMS CAN BE FOUND IN THE TABLE BELOW, AND SUPPORTING PHOTOGRAPHS ARE ATTACHED FOR YOUR REFERENCE. REF NO. DESCRIPTION SIZE LOT NO QTY RECEIVED TOTAL QTY RECEIVED IN PCS QTY REJECTED % 309658 BD PLASTIPAK SYRINGE 3ML 5015070 5BOX=1000 1000 89 8.9% 309658 BD PLASTIPAK SYRINGE 3ML 4352867 1BOX=200 200 26 13.0%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829124 ↗
• MalfunctionAug 11, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL EURO 200 S/C HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MULTIPLE SKU W/ VISIBLE PARTICLES, DEFECTIVE PLUNGERS, EXCESSIVE LUBRICANT. WHEN DID THE INCIDENT OCCUR? BEFORE USE. PLEASE NOTE THAT WE HAVE IDENTIFIED SEVERAL QUALITY DEFECTS IN THE SYRINGES RECEIVED UNDER PO: (B)(4). THE ISSUES OBSERVED INCLUDE: VISIBLE PARTICLES INSIDE THE SYRINGE, PARTICLES BETWEEN THE PLUNGER AND BARREL SPACE, MULTIPLE WHITE PARTICLES FOUND INSIDE THE PACKAGING, DEFECTIVE PLUNGERS, EXCESSIVE LUBRICANT. THE DETAILS OF THE REJECTED ITEMS CAN BE FOUND IN THE TABLE BELOW, AND SUPPORTING PHOTOGRAPHS ARE ATTACHED FOR YOUR REFERENCE. REF NO. DESCRIPTION SIZE LOT NO QTY RECEIVED TOTAL QTY RECEIVED IN PCS QTY REJECTED % 309658, BD PLASTIPAK SYRINGE, 3ML 5015070, 5BOX=1000, 1000, 89, 8.9%, 309658, BD PLASTIPAK SYRINGE, 3ML 4352867, 1BOX=200, 200 26, 13.0%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22779211 ↗
• MalfunctionAug 11, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL EURO 200 S/C HAD VISIBLE SILICONE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MULTIPLE SKU W/ VISIBLE PARTICLES, DEFECTIVE PLUNGERS, EXCESSIVE LUBRICANT WHEN DID THE INCIDENT OCCUR? BEFORE USE. PLEASE NOTE THAT WE HAVE IDENTIFIED SEVERAL QUALITY DEFECTS IN THE SYRINGES RECEIVED UNDER PO: (B)(4). THE ISSUES OBSERVED INCLUDE: VISIBLE PARTICLES INSIDE THE SYRINGE, PARTICLES BETWEEN THE PLUNGER AND BARREL SPACE, MULTIPLE WHITE PARTICLES FOUND INSIDE THE PACKAGING, DEFECTIVE PLUNGERS, EXCESSIVE LUBRICANT. THE DETAILS OF THE REJECTED ITEMS CAN BE FOUND IN THE TABLE BELOW, AND SUPPORTING PHOTOGRAPHS ARE ATTACHED FOR YOUR REFERENCE. REF NO. DESCRIPTION SIZE LOT NO QTY RECEIVED TOTAL QTY RECEIVED IN PCS QTY REJECTED % 309658, BD PLASTIPAK SYRINGE, 3ML 5015070, 5BOX=1000, 1000, 89, 8.9%, 309658, BD PLASTIPAK SYRINGE, 3ML 4352867, 1BOX=200, 200 26, 13.0%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22779210 ↗
• MalfunctionAug 11, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL EURO 200 S/C HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MULTIPLE SKU W/ VISIBLE PARTICLES, DEFECTIVE PLUNGERS, EXCESSIVE LUBRICANT. WHEN DID THE INCIDENT OCCUR? BEFORE USE. PLEASE NOTE THAT WE HAVE IDENTIFIED SEVERAL QUALITY DEFECTS IN THE SYRINGES RECEIVED UNDER PO: (B)(4). THE ISSUES OBSERVED INCLUDE: VISIBLE PARTICLES INSIDE THE SYRINGE, PARTICLES BETWEEN THE PLUNGER AND BARREL SPACE, MULTIPLE WHITE PARTICLES FOUND INSIDE THE PACKAGING, DEFECTIVE PLUNGERS, EXCESSIVE LUBRICANT. THE DETAILS OF THE REJECTED ITEMS CAN BE FOUND IN THE TABLE BELOW, AND SUPPORTING PHOTOGRAPHS ARE ATTACHED FOR YOUR REFERENCE. REF NO. DESCRIPTION SIZE LOT NO QTY RECEIVED TOTAL QTY RECEIVED IN PCS QTY REJECTED % 309658, BD PLASTIPAK SYRINGE, 3ML 5015070, 5BOX=1000, 1000, 89, 8.9%, 309658, BD PLASTIPAK SYRINGE, 3ML 4352867, 1BOX=200, 200 26, 13.0%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22779208 ↗
• MalfunctionJul 23, 2025Crack; Crack

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL EURO 200 S/C BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS MORNING WE OBSERVED TWO CRACKS IN BD 3ML LL SYRINGES: ONE CAUSED THE SYRINGE TO BREAK WHILE PREPARING A CYTOTOXIC DRUG THE OTHER CRACK WAS NOTICED BY A NURSE AFTER ADMINISTERING A CYTOTOXIC DRUG SC --> A DROP APPEARED OUTSIDE THE SYRINGE. THE BATCHES THAT MAY BE AFFECTED ARE: 5024932; 4352797; 4352796; 3073041. AS THE SYRINGES CONTAINED CYTOTOXIC PRODUCTS, WE DID NOT KEEP THEM. 10-JUL-2025 - ADDITIONAL INFORMATION RECEIVED REFERENCE NUMBER: 309658.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22583615 ↗

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-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-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-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-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-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-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-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-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