BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS

    MDR report key: 11387982 · Received February 26, 2021

    Report

    Report Number
    1920898-2021-00244
    Event Type
    Injury
    Date Received
    February 26, 2021
    Date of Event
    February 3, 2021
    Report Date
    March 29, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908466035
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-03-18. INVESTIGATION SUMMARY: CUSTOMER RETURNED (21) 1/2CC, 12.7MM, 30G SYRINGES (11 IN AN OPEN POLY BAG, 10 IN A SEALED POLY BAG) FROM LOT # 0252891. CUSTOMER STATES THAT THE SCALE MARKINGS ARE SLANTED. ALL RETURNED SYRINGES WERE TESTED USING THE PLUG GAUGE AND ALL SCALE MARKING PLACEMENTS FELL WITHIN SPECIFICATIONS. CUSTOMER STATES THAT SOME STOPPERS ARE AT A SLOPE OR INCLINE INSIDE THE BARREL. ALL RETURNED SYRINGES WERE EXAMINED AND NO DAMAGED OR DEFORMED STOPPER WAS OBSERVED IN ANY OF THE SAMPLES. CUSTOMER STATES THAT HIS NUMBERS HAVE BEEN LOW. ALL RETURNED SYRINGES WERE TESTED AND ALL WERE ABLE TO DRAW AND EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0252891. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS HAD SCALE MARKING ISSUES AND DEFORMED STOPPERS DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT SCALE MARKINGS ARE SLANTED AND SOME STOPPERS ARE AT A SLOPE OR INCLINE INSIDE THE BARREL. IT WAS ALSO REPORTED NUMBERS HAVE BEEN LOW. VERBATIM: CONSUMER REPORTED, HE'S FOUND SYRINGES PRIOR TO USE WITH "SCALE MARKINGS" THAT ARE "SLANTED", STATED, SOME OF THE SYRINGES PRIOR TO USE HAVE "STOPPERS THAT ARE AT A "SLOPE OR INCLINE" INSIDE THE BARREL STATED, HE DOES NOT USE SYRINGES WITH PROBLEMS HE IS REPORTING STATED, THE SYRINGES HE HAS USED, HIS NUMBERS HAVE BEEN LOW, (ONCE AT 47). DID NOT SEEK MEDICAL STATED, BD IS GOING TO "KILL SOMEONE IF THEY DON'T GET THESE SYRINGES RIGHT". STATED, HE TRIED TO SWITCH TO ANOTHER BRAND BUT BD IS THE ONLY SYRINGES THE PHARMACIST CAN SUPPLY TO HIM STATED, HE GETS HIS SYRINGES FROM THE (B)(6) HOSPITAL."

    Additional Manufacturer Narrative · 1

    "A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4)."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS HAD SCALE MARKING ISSUES AND DEFORMED STOPPERS DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT SCALE MARKINGS ARE SLANTED AND SOME STOPPERS ARE AT A SLOPE OR INCLINE INSIDE THE BARREL. IT WAS ALSO REPORTED NUMBERS HAVE BEEN LOW. VERBATIM: CONSUMER REPORTED, HE'S FIND SYRINGES PRIOR TO USE WITH "SCALE MARKINGS" THAT ARE "SLANTED", STATED, SOME OF THE SYRINGES PRIOR TO USE HAVE "STOPPERS THAT ARE AT A "SLOPE OR INCLINE" INSIDE THE BARREL STATED, HE DOES NOT USE SYRINGES WITH PROBLEMS HE IS REPORTING STATED, THE SYRINGES HE HAS USED, HIS NUMBERS HAVE BEEN LOW, (ONCE AT 47). DID NOT SEEK MEDICAL STATED, BD IS GOING TO "KILL SOMEONE IF THEY DON'T GET THESE SYRINGES RIGHT". STATED, HE TRIED TO SWITCH TO ANOTHER BRAND BUT BD IS THE ONLY SYRINGES THE PHARMACIST CAN SUPPLY TO HIM STATED, HE GETS HIS SYRINGES FROM THE VA HOSPITAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282906 SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328466 0252891 00382908466035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other