BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G

    MDR report key: 9918005 · Received April 2, 2020

    Report

    Report Number
    9616656-2020-00283
    Event Type
    Malfunction
    Date Received
    April 2, 2020
    Date of Event
    March 12, 2020
    Report Date
    April 8, 2020
    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
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY CUSTOMER RETURNED (B)(4) OPEN 4MM, 32G PEN NEEDLES WITHOUT THE TEAR DROP LABEL OR INNER SHIELD. CUSTOMER STATES THAT THE PEN NEEDLES WERE JAMMING AND NOT RELEASING INSULIN. ALL RETURNED PEN NEEDLES WERE EXAMINED AND ONE SAMPLE EXHIBITED A BROKEN NON PATIENT END OF THE CANNULA. ALL REMAINING SAMPLES WERE TESTED AND ALL WERE ABLE TO EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. 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 INVESTIGATION CONCLUSION BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BROKEN NON PATIENT END OF THE CANNULA). 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 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G WERE UNABLE TO DELIVER INSULIN/MEDICATION AND DIFFICULT TO OPERATE OR NOT WORKING/FUNCTIONING. THE PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122 BATCH NO: 9191533 FROM PHONE CALL ON (B)(6)2020 17:19:15: CONSUMER REPORTED, DOES NOT PRIME BEFORE USE DATE OF EVENT: UNKNOWN I RECEIVED A PHONE CALL FROM (B)(6) COMPLAINING THAT SHE GOT HER NANO PEN NEEDLES AND FOR THE LAST THREE DAYS (B)(4) OF THEM WERE JAMMING AND SHE WASN'T ABLE TO INJECT HER INSULIN. SHE SAID THAT SHE GOT THEM FROM HER (B)(6) AS ALWAYS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 6 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G WERE UNABLE TO DELIVER INSULIN/MEDICATION AND DIFFICULT TO OPERATE OR NOT WORKING/FUNCTIONING. THE PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122 BATCH NO: 9191533. FROM PHONE CALL ON (B)(6) 2020 17:19:15: CONSUMER REPORTED, DOES NOT PRIME BEFORE USE. DATE OF EVENT: UNKNOWN. I RECEIVED A PHONE CALL FROM COMPLAINING THAT SHE GOT HER NANO PEN NEEDLES AND FOR THE LAST THREE DAYS 6 OF THEM WERE JAMMING AND SHE WASN'T ABLE TO INJECT HER INSULIN. SHE SAID THAT SHE GOT THEM FROM HER AS ALWAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382733 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2865 9191533 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other