BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 11784517 · Received May 6, 2021

    Report

    Report Number
    1911916-2021-00409
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 9, 2021
    Report Date
    June 24, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: IT WAS REPORTED THE BOX CONTAINS TWO DIFFERENT NEEDLE LENGTHS. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO SHOWS TWO PACKAGING BLISTERS FROM THE BOTTOM WEB, EACH WITH A NEEDLE ASSEMBLY IN IT. ONE NEEDLE ASSEMBLY HAS A 1" LONG NEEDLE AND THE OTHER ONE IS 1/2" LONG NEEDLE. THE SECOND PHOTO SHOWS TWO PACKAGING BLISTERS TOP WEB; BOTH ARE FOR 30GX1/2" NEEDLES. THIS DEFECT CAN OCCUR IF PROPER LINE CLEARANCE WAS NOT COMPLETED DURING A CHANGE OVER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305106, LOT NUMBER 9193522. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO MITIGATE THESE ESCAPES, A SECOND REVIEWER HAS BEEN ADDED TO THE LINE CLEARANCE PROCESS. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305106, BATCH NO.: 9193522. PRODUCT 305106 (30G X ½"), LOT #9193522 - END-USER ADVISES THERE ARE 2 PROBLEMATIC BOXES: 1. ONE BOX CONTAINS A MIX OF NEEDLE LENGTHS: 30G X ½" AND 30G X 1". 2. THE OTHER BOX CONTAINS NEEDLES 30G X 1", WHICH DOES CORRESPOND TO WHAT SHOULD BE CONTAINED IN THE BOX.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305106 AND LOT NUMBER 9193522. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THIS PRODUCT AND SYMPTOM. WITH NO SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305106, BATCH NO.: 9193522. PRODUCT 305106 (30G X ½"), LOT #9193522 - END-USER ADVISES THERE ARE 2 PROBLEMATIC BOXES: ONE BOX CONTAINS A MIX OF NEEDLE LENGTHS: 30G X ½" AND 30G X 1". THE OTHER BOX CONTAINS NEEDLES 30G X 1", WHICH DOES CORRESPOND TO WHAT SHOULD BE CONTAINED IN THE BOX..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682188 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9193522

    Patients

    Seq Age Sex Outcome Treatment
    1