BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML 29GA 12.7MM

    MDR report key: 9265744 · Received November 1, 2019

    Report

    Report Number
    1920898-2019-01231
    Event Type
    Malfunction
    Date Received
    November 1, 2019
    Date of Event
    October 8, 2019
    Report Date
    December 13, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED A PHOTO OF A POLY BAG OF 1CC SYRINGES FROM LOT # 7142918. CUSTOMER STATES THAT THE NEEDLE PIERCED THROUGH THE ORANGE CAP AND SHE PRICKED HER FINGER. THE PHOTO WAS EXAMINED AND EXHIBITED ONE SYRINGE WITH THE CANNULA THROUGH THE SHIELD, EXPOSING THE CANNULA, WHICH COULD LEAD TO A NEEDLE STICK. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7142918. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200700955] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: -CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. AS PER INVESTIGATION COMPLETED BY MANUFACTURING, "ON 05DEC2019, HOLDREGE RECEIVED PHOTO OF 1.0ML 29G, 12.7MM SYRINGE IN A CLOSED POLYBAG FROM LOT #7142918. VISUAL INSPECTION OF PHOTOS FOUND THE CANNULA PIERCED THROUGH THE BOTTOM OF THE SHIELD TOWARD THE BARREL. THERE IS NO VISUAL DAMAGE TO THE SHIELD OR BARREL. THE CANNULA IS INSERTED INTO THE BARREL TIP AND ADHESIVE APPLIED TO HOLD THE CANNULA IN THE BARREL TIP. THE SUBASSEMBLY IS THEN PUT THROUGH THE POINT INSPECT LUBE SHIELD MACHINE WHERE IT IS INSPECTED, LUBE APPLIED TO CANNULA, AND THE SHIELD IS PRESSED ONTO THE BARREL/CANNULA SUBASSEMBLY AND DETECTS FOR MISSING SHIELD. REVIEW OF DHR RECORDS FOUND NO QUALITY NOTIFICATIONS THAT PERTAINED TO THIS COMPLAINT. UNABLE TO DETERMINE ROOT CAUSE OF CANNULA THROUGH THE SHIELD. CAPA 226773 REBUILT THE SHIELDER DIAL ON THE PILS MACHINE FN TO REDUCE CANNULA THROUGH SHIELD IN DECEMBER2019 AFTER THE DATE OF MANUFACTURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORT CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED AND TREND ON REPORTS MONITORED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CANNULA PIERCED THROUGH THE ORANGE SHIELD WITH A BD SYRINGE 1ML 29GA 12.7MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WHEN OPENING A BOX REF: 320841 LOT: 7142918 SHE PRICKED HER FINGER. AFTER OBSERVATION IT WAS VISIBLE THAT THE NEEDLE PIERCED THE ORANGE CAP. CLIENT ISOLATED THE BOX AND HIS INJURY IS NOT SERIOUS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CANNULA PIERCED THROUGH THE ORANGE SHIELD WITH A BD SYRINGE 1ML 29GA 12.7MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WHEN OPENING A BOX REF: 320841 LOT: 7142918 SHE PRICKED HER FINGER. AFTER OBSERVATION IT WAS VISIBLE THAT THE NEEDLE PIERCED THE ORANGE CAP. CLIENT ISOLATED THE BOX AND HIS INJURY IS NOT SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059327 BD SYRINGE 1ML 29GA 12.7MM SYRINGE FMF BD MEDICAL - DIABETES CARE 7142918

    Patients

    Seq Age Sex Outcome Treatment
    1 Other