SYRINGE 20ML E/T 300613Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00382903006137), received between Nov 28, 2017 and Sep 11, 2026 — classified as 69 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (22 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 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Unsealed Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744354 ↗
• MalfunctionSep 11, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50725162 ↗
• MalfunctionApr 1, 2026Contamination

  IT WAS REPORTED THAT THE BD SYRINGE 20ML E/T HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REF: (B)(4). LOT NUMBER: 2507059 DATE OF OCCURRENCE: 23/03/2026 DESCRIPTION OF FACTS: IT WAS REPORTED THAT SYRINGE STILL SEALED BUT FOUND CONTAMINATED FROM INSIDE WITH CLEAR TRACES OF CONTAMINATION / STAINING CONTAMINATION (SEE PHOTOS). CLINICAL CONSEQUENCES OBSERVED: NONE: SYRINGE ISOLATED AND QUARANTINED FOR INVESTIGATION. THE FLANGES ARE MARKED ¿S30¿ AND ¿44¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760474 ↗
• MalfunctionJan 14, 2026Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24075283 ↗
• MalfunctionFeb 26, 2025Contamination; Contamination

  DESCRIPTION/EVENT DETAILS: FLASHES AND FOREIGN MATERIALS WERE DISCOVERED CONTRARY TO THE AGREED UPON REQUIREMENT AND DETAILED IN THE DRAWING. DURING REGULAR INSPECTION, 3 LOT# WERE CHECKED AND FLASHES AND FOREIGN MATERIALS WERE DISCOVERED CONTRARY TO THE AGREED UPON REQUIREMENT AND DETAILED IN THE DRAWING. AS A RESULT, ALL THE BATCHES LISTED BELOW WERE REJECTED. AND THE COMPLAINT IS FOR ALL 3 LOT# : 2401017. 2401020. 2401086. ADDITIONAL INFORMATION THE FOREIGN MATERIAL IS EMENDED WITH THE DEVICE. WHEN DID THE INCIDENT OCCUR? BEFORE USE PER RESPONSE: THE FOREIGN MATERIAL IS EMENDED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468859 ↗
• MalfunctionJan 30, 2025Leak/Splash; Leak/Splash

  DESCRIPTION/EVENT DETAILS: COMMON NAME: SERINGUE BD PLASTIPAK, COMMERCIAL REFERENCE: 300613, BATCH / SERIAL NUMBER: (B)(6), DATE OF OCCURRENCE: ON (B)(6) 2025. DESCRIPTION OF NON-CONFORMIT: DURING THE INJECTION OF PROPOFOL AT INDUCTION, LEAKAGE OF PROPOFOL THROUGH THE LEAKING PLUNGER. INCOMPLETE SEAL. CONSEQUENCES: DISORGANISATION OF WORK. VIGILANCE OVER THE REST OF THE BATCH, DEVICE RETAINED FOR EXPERT APPRAISAL: YES. PLEASE GIVE US YOUR ANALYSIS OF THESE QUALITY DEFECTS AND KINDLY SEND US AN EQUIVALENT REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21279988 ↗
• MalfunctionDec 12, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912479 ↗
• MalfunctionApr 12, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  OILY SUBSTANCE VISIBLE IN THE 20ML SYRINGE. GREASY SUBSTANCE IN THE 20ML SQUIRT, EASILY VISIBLE. CUSTOMER CONCERNED ABOUT POSSIBLE HEALTH RISKS. SAME COMPLAINT WAS REPORTED ON 11-03 FOR THE 50ML SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096675 ↗
• MalfunctionMar 25, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967450 ↗
• MalfunctionMar 22, 2024Defective Component; Defective Component

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18958394 ↗
• MalfunctionFeb 9, 2024Defective Device; Defective Device

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676196 ↗
• MalfunctionOct 11, 2023Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE STOPPER ON THE 20 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE WAS LOOSE. THE FOLLOWING WAS TRANSLATED FROM FRENCH TO ENGLISH: THE RUBBER OF THE PLUNGER OF A 20ML SYRINGE IS NOT AIRTIGHT. THE LEAK OCCURRED WHILE THE SYRINGE WAS BEING USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17917003 ↗
• MalfunctionOct 4, 2023Crack; Crack

  IT WAS REPORTED WHILE USING 20 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE CE MARK THERE WAS A CRACK. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT COMPLAINT. SYRINGE HAD A CRACK ON THE BARREL. OCCURRENCE CUSTOMER HAS PRODUCT TO RETURN. PLEASE SEND CUSTOMER A RETURN KIT FOR PRODUCT INVESTIGATION. LOT# 2111059. SAP SEARCH (2 POSSIBLE MAT # 300613(PR# (B)(4)) OR 309657 (PR# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17873701 ↗
• MalfunctionAug 30, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT UNSPECIFIED NUMBER OF BD¿ ECCENTRIC LUER SLIP TIP SYRINGE EXPERIENCED IMPURITY PEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM WRITING TO YOU AGAIN FOLLOWING RECEIPT OF SYRINGE REFERENCE (B)(4). ON THE LAST ORDER LFD2036/2023 WE RECEIVED 16 CARTONS, ALL OF WHICH WERE RETURNED INTERNALLY AS NON-COMPLIANT. THE LAST BATCH RECEIVED FROM ORDER LFD5529/2022 NO. 2207133 WAS COMPLIANT. LOT 2301033: (1) LOT REFUSED BECAUSE QUANTIFIED IN BARIUM. CONCLUSION: LOT NOT IN CONFORMITY: BARIUM. BATCH 2212022: CONCLUSION: LOT NOT IN CONFORMITY: AMMONIUM. BATCH 2211058: CONCLUSION: NON-CONFORMING LOT FOR BARIUM, POTASSIUM AND ZINC - THE FOLLOWING ELEMENTS ARE RETURNED IN THE SALINE WATER MATRIX (PMI006) BECAUSE THE LIMITS OF QUANTIFICATION ARE LOWER. SILVER: < 0.1 PG/L, CALCIUM: < 0.5 MG/L, COBALT: < 0.1 PG/L, POTASSIUM: 0.261 MG/L, MAGNESIUM: < 0.5 MG/L, MANGANESE: < 0.5 PG/L, MOLYBDENUM: < 0.0001 MG/L, LEAD: < 0.25 UG/L, ANTIMONY: < 0.25 PI/L, TIN: < 0.5 UG/L. LOT 2302042: (1) LOT REFUSED BECAUSE QUANTIFIED IN BARIUM AND ZINC CONCLUSION: NON-CONFORMING LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17654894 ↗
• MalfunctionJun 20, 2023Contamination; Contamination

  IT WAS REPORTED THAT 2 BD¿ 20 ML ECCENTRIC LUER SLIP TIP SYRINGE CE HAD "BLACK" FOREIGN MATTER IN SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: OUR OPERATING ROOM FOUND A SUSPICIOUS BLACK ELEMENT IN TWO 20-ML STERILE SYRINGES FROM BD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164802 ↗
• MalfunctionMar 2, 2023Contamination; Contamination

  IT WAS REPORTED THAT EXCESSIVE AMOUNTS OF BARIUM, POTASSIUM, AND ZINC WERE FOUND IN 2 BD PLASTIPAK¿ SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE RECEIVED X2 PRODUCT 12044717 LOT2211058 ON BL3173997230. AFTER TESTING IT TURNS OUT THAT THE PRODUCT CANNOT BE USED DUE TO THE PRESENCE OF TOO MUCH BARIUM, POTASSIUM AND ZINC."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475888 ↗
• MalfunctionDec 19, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE STOPPER SEPARATED FROM THE PLUNGER DURING PRODUCT SAMPLING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "THE RUBBER PART CAME OFF DURING A PRODUCT SAMPLING... OCCURRED IN OUR RADIOLOGY UNIT. THE RUBBER PART CAME OFF DURING A PRODUCT SAMPLING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16007797 ↗
• MalfunctionSep 16, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT 3 BD PLASTIPAK¿ 20 ML SYRINGES EXPERIENCED LUER TIP DEFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THREE BD PLASTIPAK 20ML SYRINGES IDENTIFIED WITH THE LUER CONNECTION DEFORMED. UNABLE TO ATTACH NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442516 ↗
• MalfunctionAug 10, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT WHILE USING THE BD¿ PLASTIPAK LUER SLIP SYRINGES THE PLUNGER IS DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH TRANSLATED FROM FRENCH: THE SYRINGE IS DIFFICULT TO USE, THE PLUNGER IS DIFFICULT TO MOVE. THE ANESTHETIST HAD DIFFICULTIES INJECTING HIS PRODUCTS BECAUSE OF THE RESISTANCE OF THE PISTON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15200486 ↗
• MalfunctionJun 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE LEAKED PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WHEN DRAWING PROPOFOL FROM A 20ML AMPOULE WITH A 20ML SYRINGE, SOME OF THE DRUG RAN DOWN THE PLUNGER OF THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14564432 ↗
• MalfunctionMay 25, 2022Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE WAS MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS NO PRINT; NO SCALES ON THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14496310 ↗
• MalfunctionMay 24, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT LIQUID WAS FOUND IN THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ONE NURSE HAD THE IMPRESSION OF SEEING A SCRATCH IN THE BODY OF THE SYRINGE AND ON CLOSER EXAMINATION THE PRESENCE OF A LIQUID IN THE SYRINGE; LIQUID THAT CAME OUT OF THE SYRINGE AFTER PUSHING ON THE PLUNGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14492625 ↗
• MalfunctionMar 21, 2022Defective Component; Device Contamination with Chemical or Other Material; Defective Component; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE HAD A DEFECTIVE STOPPER WITH A STRING-LIKE PIECE OF FOREIGN MATTER ATTACHED TO IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) "I WOULD LIKE TO REPORT A PRODUCTION ERROR WITH A 20 ML BD SYRINGE WITH LUER. IT CONCERNS LOTNR 21112036... HOPEFULLY THIS IS A ONE-OFF FAULTY SPECIMEN, AS IT WOULD BE UNTHINKABLE TO INJECT THE PARTICLE INTO A PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13839042 ↗
• MalfunctionSep 10, 2021Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT SYRINGE 20ML E/T HAD A RESISTANCE BUILDING UP IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED SEVERAL COMPLAINTS FROM THE CLINIC THAT THE 20ML SYRINGES FROM YOU ARE SHOWING INCREASED PROBLEMS WITH OUR PUMPS AND ARE REPEATEDLY NOT WORKING. WE HAVE CHECKED EVERYTHING POSSIBLE AND CAME TO THE CONCLUSION THAT THERE IS OBVIOUSLY A GREATER RESISTANCE BUILDING UP IN THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453304 ↗
• MalfunctionJul 27, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SYRINGE 20ML E/T CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I NOTICED TODAY THAT BD PLASTIPAK 20ML AND 30ML SYRINGES PRESENTED WITH A CLEAR LIQUID SUBSTANCE RESIDUE INSIDE ONCE PLUNGER WAS PUSHED UP FULLY AND DRAWN BACK PRIOR TO USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230304 ↗

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-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-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-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-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-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