BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ SHORT PEN NEEDLES 8MM (5/16¿) 31G

    MDR report key: 10083737 · Received May 22, 2020

    Report

    Report Number
    9616656-2020-00455
    Event Type
    Malfunction
    Date Received
    May 22, 2020
    Date of Event
    May 6, 2020
    Report Date
    June 8, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403801518
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 8 JUNE 2020 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST. RELATED COMPLAINT FOR NEEDLE BREAKS OFF DURING USE FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA-FINE¿ SHORT PEN NEEDLES 8MM (5/16¿) 31G EXPERIENCED A CANNULA THAT BROKE OFF OR PULLED OUT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320109 BATCH NO: 9204815, 9162517, 9268393 & 9183074 CONSUMER INFORMED DOES NOT REUSE THE NEEDLES AND WAS ABLE TO REMOVE THE NEEDLE ON HIS OWN. NO MEDICAL ATTENTION RECEIVED. HAS THIS CURRENT BOX THAT HE IS WORKING FROM ONLY WITH ISSUES. HAS 3 OTHER BOXES SAME ITEM # WITH 3 DIFFERENT LOT # THAT HE HAS NOT USED FROM. LOT # 9162517, 9268393 & 9183074. CONSUMER REPORTED ON THREE OCCASIONS HE HAD A PEN NEEDLE BREAK OFF INTO HIS SKIN DURING HIS INJECTIONS. EXACT DATE OF EVENTS IS UNKNOWN. STATED HE WAS ABLE TO REMOVE THE NEEDLES AND DID NOT RECEIVE ANY MEDICAL ATTENTION. STATED HE MIGHT HAVE SAVED 1 SAMPLE THAT HE CAN SEND BACK TO US. STATED HE HAS 4 BOXES OF THESE PEN NEEDLES AND WANTS A REFUND ON ALL OF THEM. ADVISED CONSUMER THAT BD DOES NOT PROVIDE REFUNDS FOR 4 BOXES, CONSUMER THEN STATED HE WANTED TO SPEAK WITH A SUPERVISOR OR OR THERE WOULD BE A CLASS ACTION LAW SUIT. NOTIFIED TEAM LEAD/SUPERVISOR AND TEAM LEAD WILL BE CALLING THE CONSUMER BACK TO SPEAK WITH HIM.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9204815, MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: 2019-07-23, MEDICAL DEVICE LOT #: 9162517, MEDICAL DEVICE EXPIRATION DATE: 2024-06-30, DEVICE MANUFACTURE DATE: 2019-06-11, MEDICAL DEVICE LOT #: 9268393, MEDICAL DEVICE EXPIRATION DATE: 2024-09-30, DEVICE MANUFACTURE DATE: 2019-09-25, MEDICAL DEVICE LOT #: 9183074, MEDICAL DEVICE EXPIRATION DATE: 2024-07-31, DEVICE MANUFACTURE DATE: 2019-07-02. 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 AN UNSPECIFIED NUMBER OF BD ULTRA-FINE¿ SHORT PEN NEEDLES 8 MM (5/16¿) 31 G EXPERIENCED A CANNULA THAT BROKE OFF OR PULLED OUT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320109, BATCH NO: 9204815, 9162517, 9268393 & 9183074. CONSUMER INFORMED DOES NOT REUSE THE NEEDLES AND WAS ABLE TO REMOVE THE NEEDLE ON HIS OWN. NO MEDICAL ATTENTION RECEIVED. HAS THIS CURRENT BOX THAT HE IS WORKING FROM ONLY WITH ISSUES. HAS 3 OTHER BOXES SAME ITEM # WITH 3 DIFFERENT LOT # THAT HE HAS NOT USED FROM. LOT # 9162517, 9268393 & 9183074. CONSUMER REPORTED ON THREE OCCASIONS HE HAD A PEN NEEDLE BREAK OFF INTO HIS SKIN DURING HIS INJECTIONS. EXACT DATE OF EVENTS IS UNKNOWN. STATED HE WAS ABLE TO REMOVE THE NEEDLES AND DID NOT RECEIVE ANY MEDICAL ATTENTION. STATED HE MIGHT HAVE SAVED 1 SAMPLE THAT HE CAN SEND BACK TO US. STATED HE HAS 4 BOXES OF THESE PEN NEEDLES AND WANTS A REFUND ON ALL OF THEM. ADVISED CONSUMER THAT BD DOES NOT PROVIDE REFUNDS FOR 4 BOXES, CONSUMER THEN STATED HE WANTED TO SPEAK WITH A SUPERVISOR OR THERE WOULD BE A CLASS ACTION LAW SUIT. NOTIFIED TEAM LEAD/SUPERVISOR AND TEAM LEAD WILL BE CALLING THE CONSUMER BACK TO SPEAK WITH HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547962 BD ULTRA-FINE¿ SHORT PEN NEEDLES 8MM (5/16¿) 31G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8015 SEE H10 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Other