BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30X1/2 RB

    MDR report key: 9869342 · Received March 23, 2020

    Report

    Report Number
    1911916-2020-00290
    Event Type
    Malfunction
    Date Received
    March 23, 2020
    Date of Event
    March 2, 2020
    Report Date
    March 24, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: REASON CODE FOR NO EVALUATION: OTHER; IF OTHER SPECIFY: SEE SECTION H.10. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE 30X1/2 RB LABEL HAD INCORRECT INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THE CUSTOMER ORDERED 0.5 INCH NEEDLES BUT RECEIVED A BOX MIXED WITH 1" NEEDLES. THE BOX AND PACKAGING INDICATE 0.5" BUT THE ACTUAL PRODUCT IS 1". VERBATIM: ALSO, SO THAT YOU¿RE AWARE WE HAVE RECEIVED ANOTHER SHIPMENT ON MONDAY THIS WEEK WITH BOXES OF 30G NEEDLES FROM THE SAME LOT NUMBER (9193522) AND THESE BOXES ARE ALSO CONTAINING THE WRONG SIZED NEEDLES WITHIN THE PACKAGES. I HAVE NOT SEEN THIS OCCUR WITH OTHER LOT NUMBERS."

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: 3 PHOTOS WERE PROVIDED. TWO SHOW THE SHELF BOX AND ONE THE PACKAGING BLISTER TOP WEB. THE PREVIOUS BATCH WAS VERIFIED CONFIRMING IT WAS FOR THE SAME PRODUCT 305106- 30 X ½¿. BOTH HAVE THE SAME PLASTIC HUB COLOR AND PLASTIC SHIELD TYPE. THIS COMPLAINT IS DUPLICATE OF (B)(4) COMPLAINT. BOTH HAVE THE BAG WITH THE 305128 (30X1¿) WAS MIXED IN THE GAYLORD OF THE 305106 (30X ½¿). IT WAS NOT DETECTED AT THE MULTIVAC PACKAGING PROCESS. VERBATIM AND THE SAME PHOTOS. WHAT IT COULD HAVE HAPPENED IS THAT THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE SILICONE TO FIX IT AFTER THAT A PLASTIC SHIELD IS ASSEMBLED. THEN THEY ARE BAGGED AND LABELED. IN THIS CASE IT COULD HAVE HAPPENED THAT ONE BAG WITH THE 305128 (30X1¿) WAS MIXED IN THE GAYLORD OF THE 305106 (30X ½¿). IT WAS NOT DETECTED AT THE MULTIVAC PACKAGING PROCESS. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 4TH COMPLAINT FOR LOT # 9193522 FOR THIS TYPE OF DEFECT OR SYMPTOM. PREVIOUS COMPLAINT (B)(4). THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: NIP ASSEMBLY LINE. WHAT IT COULD HAVE HAPPENED IS THAT THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE SILICONE TO FIX IT AFTER THAT A PLASTIC SHIELD IS ASSEMBLED. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 30X1/2 RB LABEL HAD INCORRECT INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THE CUSTOMER ORDERED 0.5 INCH NEEDLES BUT RECEIVED A BOX MIXED WITH 1" NEEDLES. THE BOX AND PACKAGING INDICATE 0.5" BUT THE ACTUAL PRODUCT IS 1". VERBATIM: ALSO, SO THAT YOU¿RE AWARE WE HAVE RECEIVED ANOTHER SHIPMENT ON MONDAY THIS WEEK WITH BOXES OF 30G NEEDLES FROM THE SAME LOT NUMBER (9193522) AND THESE BOXES ARE ALSO CONTAINING THE WRONG SIZED NEEDLES WITHIN THE PACKAGES. I HAVE NOT SEEN THIS OCCUR WITH OTHER LOT NUMBERS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334101 NEEDLE 30X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 9193522 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other