BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES

    MDR report key: 13525604 · Received February 14, 2022

    Report

    Report Number
    9616656-2022-00163
    Event Type
    Malfunction
    Date Received
    February 14, 2022
    Date of Event
    February 1, 2022
    Report Date
    February 4, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS : LOT # : 1173073 ¿ DEVICE EXPIRATION DATE : 06/30/2026. DEVICE MANUFACTURE DATE : 06/22/2021. LOT # : UNKNOWN ¿ DEVICE EXPIRATION DATE : UNKNOWN. DEVICE MANUFACTURE DATE : UNKNOWN. INVESTIGATION SUMMARY : NO PHYSICAL DEVICE SAMPLES WERE RETURNED. EXEC SUMMARY - NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE COMPLAINT LOT HISTORY CHECK WAS PERFORMED AND THIS IS THE 3RD. RELATED COMPLAINT FOR NEEDLE CLOG ON LOT # 1173073. NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO REVIEW OF THE COMPLAINT LOT HISTORY CHECK FOR NEEDLE CLOG WAS PERFORMED ON THE UNKNOWN LOT # SO THE OCCURRENCE IS UNKNOWN, THE ISSUE IS UNCONFIRMED AND ROOT CAUSE CAN NOT BE DETERMINED. CAPA/SA - BASED ON THE ABOVE NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE OR PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) ARE REQUIRED AT THIS TIME. DHR REVIEW - NO DHR REVIEW CAN BE CARRIED OUT FOR THE AS THE UNKNOWN LOT NUMBER. A LOT HISTORY REVIEW FOR BATCH 1173073 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.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS : LOT # : 1173073 ¿ DEVICE EXPIRATION DATE : 06/30/2026.DEVICE MANUFACTURE DATE : 06/22/2021.LOT # : UNKNOWN ¿ DEVICE EXPIRATION DATE : UNKNOWN. DEVICE MANUFACTURE DATE : UNKNOWN. INVESTIGATION SUMMARY :NO PHYSICAL DEVICE SAMPLES WERE RETURNED. EXEC SUMMARY - NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE COMPLAINT LOT HISTORY CHECK WAS PERFORMED AND THIS IS THE 3RD. RELATED COMPLAINT FOR NEEDLE CLOG ON LOT # 1173073. NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO REVIEW OF THE COMPLAINT LOT HISTORY CHECK FOR NEEDLE CLOG WAS PERFORMED ON THE UNKNOWN LOT # SO THE OCCURRENCE IS UNKNOWN, THE ISSUE IS UNCONFIRMED AND ROOT CAUSE CAN NOT BE DETERMINED. CAPA/SA - BASED ON THE ABOVE NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE OR PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) ARE REQUIRED AT THIS TIME.DHR REVIEW - NO DHR REVIEW CAN BE CARRIED OUT FOR THE AS THE UNKNOWN LOT NUMBER. A LOT HISTORY REVIEW FOR BATCH 1173073 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 3 BD NANO¿ 2ND GEN PEN NEEDLES WERE UNABLE TO DELIVER INSULIN OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED SEVERAL NEEDLES CLOGGED DURING INJECTION AND DOES NOT COMPLETE A FLOW CHECK. DATE OF EVENT : UNKNOWN. SAMPLE STATUS : DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD NANO¿ 2ND GEN PEN NEEDLES WERE UNABLE TO DELIVER INSULIN OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED SEVERAL NEEDLES CLOGGED DURING INJECTION AND DOES NOT COMPLETE A FLOW CHECK. DATE OF EVENT : UNKNOWN. SAMPLE STATUS : DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75900 BD NANO¿ 2ND GEN PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 SEE H.10 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown