BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE PEN NEEDLES

    MDR report key: 10079652 · Received May 21, 2020

    Report

    Report Number
    9616656-2020-00447
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Date of Event
    May 7, 2020
    Report Date
    July 7, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL? YES D.10. RETURNED TO MANUFACTURER ON: 2020-06-29. H.3. DEVICE RETURNED TO MANUFACTURER: YES H.3. DEVICE EVAL BY MANUFACTURER: YES H.6. INVESTIGATION SUMMARY: LEVEL A INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR DOES NOT DETACH AS INTENDED OUTER COVER ON LOT # 9183081. INVESTIGATION SUMMARY: CUSTOMER RETURNED (64) SEALED 4MM, 32G PEN NEEDLES FROM LOT # 9183081. CUSTOMER STATES THAT SHE CANNOT REMOVE THE NEEDLE AND HUB FROM THE OUTER COVER. THIRTY OUT OF 64 RETURNED PEN NEEDLES WERE TESTED AND ALL WERE ABLE TO HAVE THE OUTER COVER REMOVED WITHOUT ANY OBSERVED DEFECTS. 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. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: - UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLE HUB CAN NOT BE REMOVED FROM THE OUTER COVER. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SHE CAN NOT REMOVE THE NEEDLE AND HUB FROM THE OUTER COVER. CONSUMER REPORTED WHEN REMOVING THE TEAR DROP LABEL FROM SOME OF THE BD NANO PEN NEEDLES IN HER CURRENT BOX, SHE CAN NOT REMOVE THE NEEDLE/HUB PIECE FROM THE OUTER PLASTIC COVER. STATED THE WHOLE PEN NEEDLE PIECE WILL NOT COME OUT OF THE OUTER COVER. STATED SHE HAS TO USE A SCREW DRIVER TO REMOVE SOME OF THEM FROM THE OUTER COVER. EXACT AMOUNT AFFECTED FROM BOX IS UNKNOWN. STATED SHE WILL SEND BACK 5 USED SAMPLES AND 5 UNUSED REP SAMPLES.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: LEVEL A INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR DOES NOT DETACH AS INTENDED OUTER COVER ON LOT # 9183081. INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLE HUB CAN NOT BE REMOVED FROM THE OUTER COVER. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SHE CAN NOT REMOVE THE NEEDLE AND HUB FROM THE OUTER COVER. CONSUMER REPORTED WHEN REMOVING THE TEAR DROP LABEL FROM SOME OF THE BD NANO PEN NEEDLES IN HER CURRENT BOX, SHE CAN NOT REMOVE THE NEEDLE/HUB PIECE FROM THE OUTER PLASTIC COVER. STATED THE WHOLE PEN NEEDLE PIECE WILL NOT COME OUT OF THE OUTER COVER. STATED SHE HAS TO USE A SCREW DRIVER TO REMOVE SOME OF THEM FROM THE OUTER COVER. EXACT AMOUNT AFFECTED FROM BOX IS UNKNOWN. STATED SHE WILL SEND BACK 5 USED SAMPLES AND 5 UNUSED REP SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541648 BD ULTRA FINE PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 9183081 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1 Other