BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 8464454 · Received March 29, 2019

    Report

    Report Number
    2243072-2019-00601
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    March 13, 2019
    Report Date
    April 11, 2019
    Manufacturer
    BECTON DICKINSON
    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

    H.6. INVESTIGATION SUMMARY: LEVEL A INVESTIGATION. COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_2__; OCCURRENCE: UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK DUE TO UNKNOWN LOT NUMBER FOR CLOG. 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. CANNOT PERFORM DHR REVIEW DUE TO UNKNOWN LOT NUMBER. 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: 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLES WERE CLOGGED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿MATERIAL NO. 320122 BATCH NO. UNKNOWN IT WAS REPORTED THAT NEEDLES WERE CLOGGED. THIS COMPLAINT HAS BEEN SPLIT INTO (B)(4) TO RECORD SAME ISSUE OF CLOG WITH AN KNOWN OCCURRENCE DATE OF (B)(6) 2019. 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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: LEVEL A INVESTIGATION. COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_2__; OCCURRENCE: UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK DUE TO UNKNOWN LOT NUMBER FOR CLOG. 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. LEVEL A EVENT NO DHR OR QN REVIEW IS REQUIRED. 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. INVESTIGATION CONCLUSION: 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 NEEDLES WERE CLOGGED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿MATERIAL NO. 320122 BATCH NO. UNKNOWN. IT WAS REPORTED THAT NEEDLES WERE CLOGGED. THIS COMPLAINT HAS BEEN SPLIT INTO (B)(4) TO RECORD SAME ISSUE OF CLOG WITH AN KNOWN OCCURRENCE DATE OF (B)(6) 2019. 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
    256004 BD ULTRA FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other