BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G

    MDR report key: 8461824 · Received March 28, 2019

    Report

    Report Number
    9616657-2019-00162
    Event Type
    Malfunction
    Date Received
    March 28, 2019
    Date of Event
    March 13, 2019
    Report Date
    April 15, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (9) 32G, 4MM BD PEN NEEDLES WITHOUT THE TEAR DROP LABELS ATTACHED, AND (1) PEN NEEDLE WITHOUT A TEAR DROP LABEL ATTACHED THAT WAS NOT MANUFACTURED BY BD. CONSUMER REPORTED 10% THE PEN NEEDLES ARE CLOGGED FROM THE BOX. THE 9 RETURNED BD PEN NEEDLES WERE EXAMINED AND THE FOLLOWING WAS OBSERVED: 7 PEN NEEDLES WITH BENT NON-PATIENT END CANNULAS. 1 PEN NEEDLE WITH A BROKEN NON-PATIENT END CANNULA. 1 PEN NEEDLE WITH GOOD PATIENT AND NON-PATIENT END CANNULA; THIS SAMPLE WAS TESTED FOR FLOW AND PASSED. 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. 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 . THE BENT OR BROKEN NEEDLES ON THE NON-PATIENT END OF THE CANNULA WOULD BE THE CAUSE FOR NO INSULIN FLOWING THROUGH, HENCE THE CUSTOMER WOULD THINK THE NEEDLE WAS CLOGGED (AS REPORTED). 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TEN BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G EXPERIENCED AN INABILITY TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: MATERIAL NO. 320122, BATCH NO. 8171657. IT WAS REPORTED THAT 10 PEN NEEDLES FROM BOX WERE CLOGGED. ALSO REPORTED DIFFERENCES IN GLUCOSE LEVELS. THIS COMPLAINT HAS BEEN SPLIT INTO PR 851622 TO RECORD SAME ISSUE OF CLOG WITH AN UNKNOWN DATE OF OCCURRENCE. VERBATIM:CONSUMER CALLED TO LET US KNOW 10% THE PEN NEEDLES ARE CLOGGED FROM THE BOX. SAMPLES AVAILABLE. HE DOESN'T PRIME. HE NOTICED HE CANNOT PUSH THE PEN, IT JAMS. WHEN HE PULLS THE PEN HE SEES WHATEVER IS STUCK IN THE PEN. HE NOTICED ABOUT 4 UNITS OF INSULIN JAMMED. HE REPORTED HE NOTICED CHANGES IN THE GLUCOSE NUMBER. LOT # 8171657. EXPIRATION - 7-31-2023. ITEM # 320122. IT HAS HAPPENED IN THE PAST. NO SAMPLES AND LOT NUMBERS ARE NOT AVAILABLE. OFFERED TO SEND A VOUCHER. HE USES NEW NEEDLE THE EACH TIME.

    Additional Manufacturer Narrative · 1

    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 5TH RELATED COMPLAINT FOR NEEDLE CLOG & THE 1ST RELATED COMPLAINT FOR GLUCOSE LEVEL ON LOT # 8171657. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. 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: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TEN BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G EXPERIENCED AN INABILITY TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: MATERIAL NO. 320122 BATCH NO. 8171657. IT WAS REPORTED THAT 10 PEN NEEDLES FROM BOX WERE CLOGGED. ALSO REPORTED DIFFERENCES IN GLUCOSE LEVELS. THIS COMPLAINT HAS BEEN SPLIT INTO PR (B)(4) TO RECORD SAME ISSUE OF CLOG WITH AN UNKNOWN DATE OF OCCURRENCE. VERBATIM: CONSUMER CALLED TO LET US KNOW 10% THE PEN NEEDLES ARE CLOGGED FROM THE BOX. SAMPLES AVAILABLE. HE DOESN'T PRIME. HE NOTICED HE CANNOT PUSH THE PEN, IT JAMS. WHEN HE PULLS THE PEN HE SEES WHATEVER IS STUCK IN THE PEN. HE NOTICED ABOUT 4 UNITS OF INSULIN JAMMED. HE REPORTED HE NOTICED CHANGES IN THE GLUCOSE NUMBER. LOT # 8171657. EXPIRATION - 7-31-2023. ITEM # 320122. IT HAS HAPPENED IN THE PAST. NO SAMPLES AND LOT NUMBERS ARE NOT AVAILABLE. OFFERED TO SEND A VOUCHER. HE USES NEW NEEDLE THE EACH TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255681 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. 8171657 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other