BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES

    MDR report key: 13233108 · Received January 11, 2022

    Report

    Report Number
    9616656-2021-01645
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    December 16, 2021
    Report Date
    March 31, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1012827. MEDICAL DEVICE EXPIRATION DATE: 2026-01-31. DEVICE MANUFACTURE DATE: 2021-01-12. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 31-MAR-2022. H.6. INVESTIGATION: CUSTOMER RETURNED (3) OPEN 4MM, 32G PEN NEEDLES WITHOUT THE TEAR DROP LABEL. CUSTOMER STATES THAT THE TEAR DROP LABEL WAS MISSING. ALL RETURNED PEN NEEDLES WERE EXAMINED AND ALL EXHIBITED A HEAT STAKE ON THE WATER OF THE OUTER COVER, INDICATING THAT ALL SAMPLES WERE PROPERLY SEALED WITH A TEAR DROP LABEL. 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. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TEAR DROP LABEL WAS MISSING AND STERILITY WAS COMPROMISED WITH THE BD NANO¿ 2ND GEN PEN NEEDLES. THERE WERE 6 PEN NEEDLES FROM AN UNKNOWN LOT# AND 3 WITH LOT# 1012827. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED MISSING TEARDROP LABEL IN 2 BOXES OF PRODUCT. CONSUMER STATED PREVIOUS BOX HAD 6 AFFECTED PEN NEEDLES & CURRENT BOX HAS 3 AFFECTED PEN NEEDLES. CONSUMER WAS UNABLE TO PROVIDE CATALOG/LOT # FOR PREVIOUS BOX; PRODUCT DESCRIPTION: BD NANO 2ND GEN PEN NEEDLES. PREVIOUS BOX CATALOG: UNKNOWN. LOT: UNKNOWN. DATE OF EVENT: UNKNOWN. SAMPLES: NO. CURRENT BOX CATALOG: 320550. LOT: 1012827 DATE OF EVE.NT: UNKNOWN. SAMPLES: AVAILABLE, SENDING MAIL KIT MKB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TEAR DROP LABEL WAS MISSING AND STERILITY WAS COMPROMISED WITH THE BD NANO¿ 2ND GEN PEN NEEDLES. THERE WERE 6 PEN NEEDLES FROM AN UNKNOWN LOT# AND 3 WITH LOT# 1012827. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED MISSING TEARDROP LABEL IN 2 BOXES OF PRODUCT. CONSUMER STATED PREVIOUS BOX HAD 6 AFFECTED PEN NEEDLES & CURRENT BOX HAS 3 AFFECTED PEN NEEDLES. CONSUMER WAS UNABLE TO PROVIDE CATALOG/LOT # FOR PREVIOUS BOX; PRODUCT DESCRIPTION: BD NANO 2ND GEN PEN NEEDLES. PREVIOUS BOX. CATALOG: UNKNOWN. LOT: UNKNOWN. DATE OF EVENT: UNKNOWN. SAMPLES: NO. CURRENT BOX. CATALOG: 320550. LOT: 1012827. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE, SENDING MAIL KIT MKB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TEAR DROP LABEL WAS MISSING AND STERILITY WAS COMPROMISED WITH THE BD NANO¿ 2ND GEN PEN NEEDLES. THERE WERE 6 PEN NEEDLES FROM AN UNKNOWN LOT# AND 3 WITH LOT# 1012827. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED MISSING TEARDROP LABEL IN 2 BOXES OF PRODUCT. CONSUMER STATED PREVIOUS BOX HAD 6 AFFECTED PEN NEEDLES & CURRENT BOX HAS 3 AFFECTED PEN NEEDLES. CONSUMER WAS UNABLE TO PROVIDE CATALOG/LOT # FOR PREVIOUS BOX; PRODUCT DESCRIPTION: BD NANO 2ND GEN PEN NEEDLES. PREVIOUS BOX: CATALOG: UNKNOWN. LOT: UNKNOWN. DATE OF EVENT: UNKNOWN. SAMPLES: NO. CURRENT BOX: CATALOG: 320550. LOT: 1012827. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE, SENDING MAIL KIT MKB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731942 BD NANO¿ 2ND GEN PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 SEE H10 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown