BD Pet Syringes, 0.5mL x 12MM U-40 323001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382903230013), received between Aug 11, 2020 and Mar 2, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2024Leak/Splash; Leak/Splash

  PET OWNER REPORTED FINDING ONE SYRINGE WITH A HOLE IN THE BARREL PRIOR TO INJECTION. STATED, SHE NOTICED THE HOLE WHEN THE BARREL WAS LEAKING AND SHE HAD A DIFFICULT TIME DRAWING. STATED, SHE FOUND A SECOND SYRINGE MISSING THE PLUNGER ROD PRIOR TO INJECTION. LOT: 2213881 CATALOG: 323001 DATE OF EVENT: UNKNOWN SAMPLES: YES CALLING BACK WITH LOT NUMBER CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18823428 ↗
• MalfunctionJan 14, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED 5 BD PET SYRINGES 1/2ML 12.7MM X 29G HAD INCORRECT LABEL INFORMATION ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FINDING 5 BOXES WITH THE LABEL OF EXP DATE AND MANUFACTURE DATE TO BE SWITCHED ON BOXES ONLY NOT BAGS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13257639 ↗
• MalfunctionOct 1, 2020Material Puncture/Hole; Material Protrusion/Extrusion; Material Puncture/Hole; Material Protrusion/Extrusion

  IT WAS REPORTED THAT VET SYRINGE 0.5ML X 29G X 12.7MM 10 BAG NEEDLE WENT THROUGH THE SHIELD AND CAUSED A NEEDLESTICK INJURY. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 323001 BATCH NO. 9126619. IT WAS REPORTED THAT NEEDLE WENT THROUGH THE SHIELD AS HE WAS RE-SHIELDING AND THE CUSTOMER WAS STUCK BY THE NEEDLE AS HE WAS HOLDING THE SHIELD. EVENT DESCRIPTION VIA PHONE CALL STATES: PET OWNER REPORTED THAT THE NEEDLE WENT THROUGH THE SHIELD AS HE WAS RE-SHIELDING. CONSUMER'S FINGER WAS STUCK BY THE NEEDLE AS HE WAS HOLDING THE SHIELD, NO INJURY, NO MEDICAL ASSISTANCE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 10614412 ↗
• MalfunctionAug 11, 2020Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  IT WAS REPORTED THAT VET SYRINGE 0.5ML X 29G X 12.7MM 10 BAG PLUNGER WAS DIFFICULT TO MOVE AND IT WAS UNABLE TO PROPERLY ASPIRATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:323001 BATCH NO: 9126619 IT WAS REPORTED THAT THE CONSUMER IS FINDING THE SYRINGES DIFFICULT TO USE AS WELL AS THE RED NEEDLE CAP DIFFICULT TO REMOVE. ALSO, THE SYRINGE BARREL DOES NOT SLIDE VERY EASILY INSIDE THE SYRINGE WHEN ATTEMPTING TO DRAW UP THE DOSES OR ADMINISTER THEM. VERBATIM: FROM PHONE CALL ON 2020-07-30 10:53:53: PET OWNER REPORTED PLUNGERS ON SYRINGES VERY HARD TO MOVE. BOTH FOR DRAWING UP AIR AND ALSO DRAWING UP INSULIN. PET OWER REPORTED RED NEEDLE SHIELDS HARD TO REMOVE TOO. VERBATIM FROM EMAIL: OUR DOG WAS RECENTLY DIAGNOSED WITH DIABETES THAT REQUIRES TREATMENT WITH INSULIN. WE GOT A SUPPLY OF U-40 12.7 MM, 0/5ML BD PET SYRINGES. I AM FINDING THAT THEY ARE MORE DIFFICULT TO USE THAN OTHER U-40 SYRINGES. THE RED NEEDLE CAP IS QUITE DIFFICULT TO REMOVE AND THE SYRINGE BARREL DOES NOT SLIDE VERY EASILY INSIDE THE SYRINGE WHEN ATTEMPTING TO DRAW UP THE DOSES OR ADMINISTER THEM. IT MAKES BEING PRECISE WHEN DRAWING UP THE DOSE, AS WELL AS BEING QUICK AND SMOOTH WHE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10394508 ↗