BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)

    MDR report key: 15460531 · Received September 21, 2022

    Report

    Report Number
    9616656-2022-01017
    Event Type
    Malfunction
    Date Received
    September 21, 2022
    Date of Event
    August 26, 2022
    Report Date
    November 2, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 0274099 D4: MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2025 H4: DEVICE MANUFACTURE DATE: 30-SEP-20 D4: MEDICAL DEVICE LOT #: 9338807 D4: MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2024 H4: DEVICE MANUFACTURE DATE: 04-DEC-2019.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 30-SEP-2022. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (51) TOTAL 32GX4MM BD PEN NEEDLES (40 FROM LOT# 0274099, 5 FROM LOT# 9338807, AND 6 FROM LOT# 1223681). THE CUSTOMER REPORTED THAT THE GLUE IS SEPARATING FROM THE PAPER TAB, THE HUB IS FALLING APART/BROKEN/NOT GLUED TOGETHER PROPERLY. THE SAMPLES WERE EXAMINED, AND IT WAS OBSERVED THAT ALL 51 PEN NEEDLES FEATURED OUTER COVERS AND TEAR DROP LABELS WITH COINCIDING HEAT STAKES, INDICATING THAT THE PEN NEEDLES HAD BEEN PROPERLY SEALED. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. THE ALLEGED ISSUES COULD NOT BE CONFIRMED BASED ON THE SAMPLES RETURNED FOR 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) THE GLUE ON THE TEARDROP LABEL WAS NOT SECURE, CAUSING A STERILITY BREACH. THIS OCCURRED 12 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED THE NON PATIENT END PART TO PEN, THE GLUE IS SEPARATING FROM THE PAPER TAB AND NOT THE NEEDLE. FEELS BECAUSE ITS BEEN VERY HOT THE GLUE AND PAPER TAB PEELED AWAY FROM EACH OTHER. CONSUMER STATED PRIOR TO USE, THE HUB IS FALLING APART, "ITS BROKEN" "NOT GLUED TOGETHER PROPERLY" IS THE WORDS HE USED. 12 PEN NEEDLES AFFECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) THE GLUE ON THE TEARDROP LABEL WAS NOT SECURE, CAUSING A STERILITY BREACH. THIS OCCURRED 12 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED THE NON PATIENT END PART TO PEN, THE GLUE IS SEPARATING FROM THE PAPER TAB AND NOT THE NEEDLE. FEELS BECAUSE ITS BEEN VERY HOT THE GLUE AND PAPER TAB PEELED AWAY FROM EACH OTHER. D C. CONSUMER STATED PRIOR TO USE, THE HUB IS FALLING APART, "ITS BROKEN" "NOT GLUED TOGETHER PROPERLY" IS THE WORDS HE USED. 12 PEN NEEDLES AFFECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) THE GLUE ON THE TEARDROP LABEL WAS NOT SECURE, CAUSING A STERILITY BREACH. THIS OCCURRED 12 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED THE NON PATIENT END PART TO PEN, THE GLUE IS SEPARATING FROM THE PAPER TAB AND NOT THE NEEDLE. FEELS BECAUSE ITS BEEN VERY HOT THE GLUE AND PAPER TAB PEELED AWAY FROM EACH OTHER. D C . CONSUMER STATED PRIOR TO USE, THE HUB IS FALLING APART, "ITS BROKEN" "NOT GLUED TOGETHER PROPERLY" IS THE WORDS HE USED. 12 PEN NEEDLES AFFECTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554114 BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 1223681 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown