BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 100BX 1200 USA

    MDR report key: 10715655 · Received October 21, 2020

    Report

    Report Number
    9616656-2020-01048
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    October 6, 2020
    Report Date
    December 9, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: 2020-12-04 H.3. DEVICE RETURNED TO MANUFACTURER: YES H.3. DEVICE EVAL BY MANUFACTURER: YES H.6. INVESTIGATION SUMMARY: LEVEL B INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND. RELATED COMPLAINT FOR NEEDLE CLOG & THE 1ST RELATED COMPLAINT FOR DOES NOT DETACH AS INTENDED ON LOT # 9183081. INVESTIGATION SUMMARY: CUSTOMER RETURNED (10) USED 32GX4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS ATTACHED. CONSUMER REPORTED THAT INSULIN DOES NOT COME OUT DURING INJECTION; ALSO REPORTED REMOVING THE PEN NEEDLE WITH DIFFICULTIES. ALL 10 PEN NEEDLES WERE EXAMINED, AND IT WAS OBSERVED THAT 8 EXHIBITED BENT NON-PATIENT END (NPE) CANNULAS, AND 2 EXHIBITED BROKEN NPE CANNULAS. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. THE BENT AND BROKEN NPE CANNULAS WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THE PEN NEEDLES WERE CLOGGED. THE BENT AND BROKEN NPE CANNULAS COULD ALSO BE THE CAUSE FOR DIFFICULTIES WHEN REMOVING THE PEN NEEDLES DUE TO THE NPE CANNULA BEING BENT AND OBSTRUCTING THE THREADS. SINCE ALL 10 SAMPLES WERE RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BENT AND BROKEN NPE CANNULAS IS USER ERROR WHILE ATTACHING THE PEN NEEDLES TO A PEN INJECTOR. 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: - CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (NPE CANNULA BENT, NPE CANNULA BROKEN) 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: THE POSSIBLE ROOT CAUSE FOR THIS ISSUE IS: USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. IT IS BD¿S EXPERIENCE THAT THE NON-PATIENT END BREAKAGE AND BENDING IS DIRECTLY ASSOCIATED WITH THE PLACING OF THE NEEDLE ONTO THE PEN DEVICE BY THE USER. IF THE NON-PATIENT END OF THE NEEDLE IS NOT PLACED CENTRALLY TO THE PEN DEVICE, THEN INSTEAD OF THE NON-PATIENT END OF THE NEEDLE PIERCING THE RUBBER SEPTUM OF THE VIAL, IT HITS HARD MATERIAL AND CAN BE BENT/BROKEN WHEN FITTED TO THE PEN. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NDL 32G 4MM 100BX 1200 USA WOULD NOT ALLOW INSULIN TO COME OUT DURING INJECTION AND THE PEN NEEDLE WAS DIFFICULT TO REMOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320122 BATCH NO. 9183081 IT WAS REPORTED THAT INSULIN DOES NOT COME OUT DURING INJECTION. ALSO REPORTED REMOVING THE PEN NEEDLE WITH DIFFICULTIES. VERBATIM: CONSUMER REPORTED COMPLETES THE FLOW CHECK AND DOES NOT SEE INSULIN COME OUT. TRIED TO COMPLETE INJECTION, THE DOSE BUTTON STOPS MIDWAY. TAKES 16 UNITS. CLAIMS TO REMOVE THE PEN NEEDLE WITH DIFFICULTIES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: LEVEL B INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT FOR NEEDLE CLOG & THE 1ST RELATED COMPLAINT FOR DOES NOT DETACH AS INTENDED ON LOT # 9183081. A REVIEW OF RISK MANAGEMENT DOCUMENT (B)(4) INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (PEN NEEDLE, NEEDLE CLOG, DOES NOT DETACH AS INTENDED) WAS CAPTURED AND ADDRESSED. 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 PEN NDL 32G 4MM 100BX 1200 USA WOULD NOT ALLOW INSULIN TO COME OUT DURING INJECTION AND THE PEN NEEDLE WAS DIFFICULT TO REMOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320122 BATCH NO. 9183081. IT WAS REPORTED THAT INSULIN DOES NOT COME OUT DURING INJECTION. ALSO REPORTED REMOVING THE PEN NEEDLE WITH DIFFICULTIES. VERBATIM: CONSUMER REPORTED COMPLETES THE FLOW CHECK AND DOES NOT SEE INSULIN COME OUT. TRIED TO COMPLETE INJECTION, THE DOSE BUTTON STOPS MIDWAY. TAKES 16 UNITS. CLAIMS TO REMOVE THE PEN NEEDLE WITH DIFFICULTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180530 PEN NDL 32G 4MM 100BX 1200 USA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2865 9183081 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1