BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE

    MDR report key: 13709998 · Received March 9, 2022

    Report

    Report Number
    1920898-2022-00150
    Event Type
    Malfunction
    Date Received
    March 9, 2022
    Date of Event
    February 20, 2022
    Report Date
    March 24, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903055006
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 29-MAR-2022. H.6. INVESTIGATION: CUSTOMER RETURNED (1) 1ML, 12.7MM, 28G BD ALLERGY SYRINGE IN AN OPEN POLY BAG FROM LOT # 1123578 AND A PHOTO OF A 1CC SYRINGE WITHOUT AND PACKAGING. CUSTOMER RETURNED A PHOTO OF A 1CC SYRINGE WITHOUT ANY PACKAGING. CUSTOMER STATES THAT THE NEEDLE WAS BENT AND THE TIP CAP WAS MISSING. THE PHOTO WAS EXAMINED AND EXHIBITED A MISSING SHIELD AND A BENT CANNULA. DUE TO THE BATCH BEING UNKNOWN, NO DHR REVIEW CAN BE COMPLETED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE SAMPLE IS SHOWN OUT OF THE PACKAGING AND POTENTIALLY OPENED/USED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE THE STERILITY WAS COMPROMISED BEFORE USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATED THAT THERE WAS A SINGLE SYRINGE IN HIS PACK OF 10 THAT DID NOT HAVE A CAP ON IT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE THE STERILITY WAS COMPROMISED BEFORE USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATED THAT THERE WAS A SINGLE SYRINGE IN HIS PACK OF 10 THAT DID NOT HAVE A CAP ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492233 BD ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 305500 UNKNOWN 30382903055006

    Patients

    Seq Age Sex Outcome Treatment
    1 Male