BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 8932750 · Received August 26, 2019

    Report

    Report Number
    9616656-2019-00791
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Date of Event
    August 6, 2019
    Report Date
    September 10, 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
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED FIVE (5) USED 32G X 4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS ATTACHED. CONSUMER REPORTED NOTHING COMES OUT OF THE PEN NEEDLE DURING THE PRIMING. ALL FIVE RETURNED SAMPLES WERE EXAMINED, AND IT WAS OBSERVED THAT ALL FIVE PEN NEEDLES HAD BENT NON-PATIENT END (NPE) CANNULAS; HOWEVER, NO EVIDENCE OF MANUFACTURING DEFECTS WAS OBSERVED. SINCE ALL FIVE SAMPLES WERE RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BENT NPE CANNULAS IS USER ERROR WHEN ATTACHING THE PEN NEEDLES TO A PEN INJECTOR. THE BENT NPE CANNULAS WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THE PEN NEEDLES WERE CLOGGED (AS REPORTED). 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 (BENT NPE CANNULA). 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. 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. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEEDLE CLOG OCCURRED DURING USE WITH A BD ULTRA FINE¿ PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONSUMER REPORTED NOTHING COMES OUT OF THE PEN NEEDLE DURING THE PRIMING. HE USES NEW PEN NEEDLE EACH TIME OF HIS INJECTION. HE ROTATES THE SKIN SITE FOR HIS INJECTION EACH TIME. HE VISUALLY TESTS THE NEEDLE TO SEE IF IT IS STRAIGHT. HE DOES NOT ATTACHES THE PEN NEEDLE VERY TIGHTLY. EXPLAINED CONSUMER NOT TO TIGHTEN THE PEN NEEDLE WHILE ATTACHING. INCIDENT DATE-(B)(6)2019; OCCURENCE-3. SAMPLE AVAILABLE . ITEM# 320122; LOT# 9071866; EXPIRATION DATE- 2024-03-31. NOTHING CAME OUT OF THE PEN NEEDLE FROM THE OTHER BOX IN THE PAST. SAMPLE DISCARDED. ITEM# 320122;OCCURENCE-UNKNOWN. ABOUT 2 OR 3 TIMES OCCURRED LESS FREQUENTLY." 3 OCCURRENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    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 A NEEDLE CLOG OCCURRED DURING USE WITH A BD ULTRA FINE¿ PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONSUMER REPORTED NOTHING COMES OUT OF THE PEN NEEDLE DURING THE PRIMING. HE USES NEW PEN NEEDLE EACH TIME OF HIS INJECTION. HE ROTATES THE SKIN SITE FOR HIS INJECTION EACH TIME. HE VISUALLY TESTS THE NEEDLE TO SEE IF IT IS STRAIGHT. HE DOES NOT ATTACHES THE PEN NEEDLE VERY TIGHTLY. EXPLAINED CONSUMER NOT TO TIGHTEN THE PEN NEEDLE WHILE ATTACHING. INCIDENT DATE- (B)(6) 2019; OCCURENCE- 3. SAMPLE AVAILABLE . ITEM# 320122; LOT# 9071866; EXPIRATION DATE- 2024-03-31. NOTHING CAME OUT OF THE PEN NEEDLE FROM THE OTHER BOX IN THE PAST. SAMPLE DISCARDED. ITEM# 320122; OCCURENCE- UNKNOWN. ABOUT 2 OR 3 TIMES OCCURRED LESS FREQUENTLY." 3 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727092 BD ULTRA FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9071866 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other