BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE, 30 G

    MDR report key: 15199696 · Received August 10, 2022

    Report

    Report Number
    1911916-2022-00417
    Event Type
    Malfunction
    Date Received
    August 10, 2022
    Date of Event
    June 20, 2022
    Report Date
    August 23, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 17-AUG-2022. H6: INVESTIGATION SUMMARY: IT WAS REPORTED THE SHARP END OF NEEDLE WAS PROTRUDING FROM CAP. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING BLISTER AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. THE SAMPLES HAS THE PLASTIC SHIELD AND A SECOND CANNULA ATTACHED TO THE NEEDLE HUB. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. THIS DEFECT COULD OCCUR DURING THE ASSEMBLY PROCESS. DURING MANUFACTURING, THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE WHITE EPOXY TO FIX IT; AFTER THAT, A PLASTIC SHIELD IS ASSEMBLED. IN THIS CASE, THE MISFEEDING OF THE CANNULATOR MAY HAVE INDUCED TO HAVE THE DOUBLE NEEDLE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305106, LOT NUMBER 1335483. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE CANNULATOR WAS PERFORMED. THE SETTINGS WERE CORRECT AND THE FLOW OF PRODUCT WAS GOOD. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE OPENING THE BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE, 30 G, DURING PROCEDURE, SHARP END OF NEEDLE WAS PROTRUDING FROM CAP END. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 305106 LOT #:1335483. IT WAS REPORTED BY THE CUSTOMER THAT "WHILE OPENING PACKAGE DURING PROCEDURE, SHARP END OF NEEDLE WAS PROTRUDING FROM CAP END." VERBATIM: BD1 - BD305106 - EXTERNALREF:150245 - WHILE OPENING PACKAGE DURING PROCEDURE, SHARP END OF NEEDLE WAS PROTRUDING FROM CAP END.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE OPENING THE BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE, 30 G, DURING PROCEDURE, SHARP END OF NEEDLE WAS PROTRUDING FROM CAP END. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 305106; LOT #:1335483. IT WAS REPORTED BY THE CUSTOMER THAT "WHILE OPENING PACKAGE DURING PROCEDURE, SHARP END OF NEEDLE WAS PROTRUDING FROM CAP END." VERBATIM: BD1 - BD305106 - EXTERNAL REF: (B)(4): WHILE OPENING PACKAGE DURING PROCEDURE, SHARP END OF NEEDLE WAS PROTRUDING FROM CAP END. IMAGE ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405501 BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE, 30 G HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 1335483 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown