N/A 304406Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 50382903044066), received between Nov 13, 2018 and Mar 1, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2022Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE USING A BD¿ LUER SLIP TIP SYRINGE GAMMA IRRADIATED (LOW DOSE), 10 ML, LEAKAGE AND A CRACK IN SYRINGE BARREL WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE WAS DETECTED DURING PRIMING. IT WAS OBSERVED ONE CRACK APPROXIMATELY 0.55" IN LENGTH AT THE TIP OF THE SYRINGE BARREL. LEAKAGE OCCURRED FROM THE CRACK ON SYRINGE BARREL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636412 ↗
• MalfunctionJun 16, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE SYRINGE 10ML LUER-LOK GAMMA IRRADIATED LEAKED FROM THE DAMAGED LUER-LOCK TIP AND CRACKED BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORT OF ISSUE OF "PLUNGER WAS UNABLE TO BE PULLED" WAS NOT CONFIRMED DURING EVALUATION, HOWEVER, LEAKAGE WAS OBSERVED FROM CO-SET SYRINGE TIP AREA. CHECKVALVES OF FLOTHRU HOUSING FUNCTIONED PROPERLY DURING PRIMING USING COSET SYRINGE FROM LAB." "TIP OF RETURNED SYRINGE DIMENSIONALLY PASSED ISO STANDARD. LEAKAGE OCCURRED FROM A CRACK BETWEEN THE TIP LUER LOCK AND SYRINGE BARREL. DAMAGE WAS ALSO NOTICED FROM THE THREADS OF THE LUER LOCK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12007760 ↗
• MalfunctionFeb 11, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 10ML LUER-LOK GAMMA IRRADIATED HAD A CRACK AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 304406, BATCH NO.: 8324556. IT WAS REPORTED THAT THERE IS A CRACK AROUND THE BOTTOM OF THE LUER LOCK HUB AND THERE WAS LEAKAGE BACK INTO THE PLUNGER PORTION OF THE SYRINGE. PER SUPPLIER NOTIFICATION. CUSTOMER REPORT "LEAKAGE WAS AT THE HUB" WAS NOT CONFIRMED. RETURNED COSET SYRINGE WAS CONNECTED TO FLOW-THROUGH HOUSING AND SWAN-GANZ CATHETER MODEL 151F7 FROM LAB FOR PRIMING. NO LEAKAGE WAS DETECTED FROM THE SYRINGE DURING PRIMING. HOWEVER CRACKS WAS FOUND AROUND THE BOTTOM OF THE LUER LOCK. THE CRACKS DID NOT EXTEND TO THE BARREL OR MALE LUER OF THE SYRINGE THUS DID NOT CAUSE ANY LEAKAGE. CUSTOMER REPORT OF "LEAKING BACK INTO THE PLUNGER PORTION OF THE SYRINGE" WAS ALSO NOT CONFIRMED. COSET SYSTEM WAS PRIMED AND WENT THROUGH MULTIPLE CYCLES OF ASPIRATION AND INJECTION AT RATE 10CC IN 4 SECONDS (AS RECOMMENDED BY VIGILANCE USER MANUAL). NO LEAKAGE WAS DETECTED FROM THE COSET SYSTEM DURING THE CYCLES OF ASPIRATION AND INJECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11317300 ↗
• MalfunctionJan 18, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 10ML LUER-LOK GAMMA IRRADIATED LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO.: 304406, BATCH NO.: 8324556. IT WAS REPORTED THAT MULTIPLE CRACKS AT THE LUER LOCK AREA OF THE SYRINGE WHICH LEAD TO LEAKING. CRACK- LEAK: CUSTOMER REPORT OF "LEAKING" WAS CONFIRMED. LEAKAGE WAS DETECTED AT THE TIP OF THE COSET SYRINGE DURING PRIMING. MULTIPLE CRACKS WERE OBSERVED AT THE LUER LOCK AREA OF THE SYRINGE. THE CRACK ALSO EXTENDED TO THE SYRINGE BARREL, APPROXIMATELY 0.55" IN LENGTH. LEAKAGE OCCURRED FROM THE CRACK ON SYRINGE BARREL. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM THE COSET SYSTEM. ENGINEERING TASK ASSIGNED FOR FURTHER INVESTIGATION."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11190477 ↗
• MalfunctionNov 13, 2018Component Missing

  IT WAS REPORTED THAT A BOX OF BD¿ SLIP TIP SYRINGES ARRIVED WITH BAG LABEL MISSING AND LINER BAG MISSING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8066920 ↗

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-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-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-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-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