BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31GA 5MM 100BX 1200 USA

    MDR report key: 11713330 · Received April 23, 2021

    Report

    Report Number
    9616656-2021-00431
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 27, 2021
    Report Date
    May 12, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201198
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NDL 31GA 5MM 100BX 1200 USA NEEDLE BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320119 BATCH NO. 7130913 IT WAS REPORTED THAT NEEDLES ARE BREAKING OFF IN INJECTION SITE. NO MEDICAL ATTENTION SOUGHT. VERBATIM: FROM PHONE CALL ON (B)(6) 2021 12:11:08: CONSUMER INFORMED SEVERAL TIMES, FROM THIS BOX ONLY, THE NEEDLE BROKE INTO HIS INJECTION SITE - ARMS AND AB AREA. CONSUMER DENIED REUSE OF NEEDLES. CONSUMER DID NOT SEEK MEDICAL ATTENTION, WAS ABLE TO REMOVE ALL NEEDLES ON HIS OWN. CONSUMER DID NOT HAVE BOX WITH HIM AT THIS TIME OF CALL BUT BELIEVED THEY WERE A RETAIL PURCHASE OF THE PURPLE/MINI BD PEN NEEDLES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEN NDL 31GA 5MM 100BX 1200 USA NEEDLE BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320119, BATCH NO. 7130913. IT WAS REPORTED THAT NEEDLES ARE BREAKING OFF IN INJECTION SITE. NO MEDICAL ATTENTION SOUGHT. VERBATIM: FROM PHONE CALL ON (B)(6) 2021 12:11:08: CONSUMER INFORMED SEVERAL TIMES, FROM THIS BOX ONLY, THE NEEDLE BROKE INTO HIS INJECTION SITE - ARMS AND AB AREA. CONSUMER DENIED REUSE OF NEEDLES. CONSUMER DID NOT SEEK MEDICAL ATTENTION, WAS ABLE TO REMOVE ALL NEEDLES ON HIS OWN. CONSUMER DID NOT HAVE BOX WITH HIM AT THIS TIME OF CALL BUT BELIEVED THEY WERE A RETAIL PURCHASE OF THE PURPLE/MINI BD PEN NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615026 PEN NDL 31GA 5MM 100BX 1200 USA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320119 7130913 00382903201198

    Patients

    Seq Age Sex Outcome Treatment
    1