BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITACRE 27GA 3-1/2IN

    MDR report key: 8302464 · Received February 4, 2019

    Report

    Report Number
    3003152976-2019-00125
    Event Type
    Injury
    Date Received
    February 4, 2019
    Date of Event
    January 11, 2019
    Report Date
    March 6, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO NON-CONFORMANCES WERE FOUND DURING DHR REVIEW (FINAL LOT 1707008). THE SPINAL NEEDLE LOT WAS MANUFACTURED IN PUERTO RICO. 74 UNOPEN SAMPLES WERE RECEIVED. HOWEVER, ONLY 6 SAMPLES BELONG TO THE LOT INVOLVED IN THE COMPLAINT. ONLY THOSE SAMPLES WERE EVALUATED DURING THE INVESTIGATION. 2 PICTURES WERE RECEIVED. IN ONE OF THE SAMPLES FM WAS FOUND, IT SEEMS METALLIC. IT IS VERY SMALL AND DOES NOT BELONG TO ANY MARK ON THE SURFACE OF THE NEEDLE. IT CAN BE REMOVED FROM THE SURFACE. THE 6 SAMPLES WERE EVALUATED AND NO NICKS OR MARKS WERE FOUND IN THE SURFACE OF THE NEEDLES (OBSERVATION UNDER MICROSCOPE). 2 PICTURES WERE RECEIVED. ONE PICTURE SHOWS THE LOT INVOLVED IN THE COMPLAINT. THE OTHER ONE SHOWS THE NEEDLE BROKEN AND BENT. JUNCOS DHR: DHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE BD JUNCOS 405159 (SPINAL NEEDLE 27 X 3 1/2IN WHITACRE BULK) LOT 6216954. BATCH WAS MANUFACTURED UNDER SUB ASSEMBLY CATALOG 700006011 LOT 6211510 PRODUCTION ORDER 101064918 FROM 02 AUG 2016 TO 04 AUG 2016 ON INSERT MOLDING MACHINE TIC #2. THIS LOT COMPRISES EIGHT (8) MANUFACTURING SHIFTS IN WHICH IN PROCESS INSPECTIONS WERE PERFORMED AT SHIFT START UP ON 32 SAMPLES (8 SAMPLES PER CAVITY) AND EVERY 4 HOURS ON 16 SAMPLES (4 SAMPLES PER CAVITY) FOR CANNULA INSPECTION THAT COVERS COSMETIC APPEARANCE OF CANNULA/STYLET, ANGULARITY; AMONG OTHER VISUAL CHARACTERISTICS AND FUNCTIONAL AS PULL FORCE TEST THAT IS PERFORMED ON 16 UNITS (4 P/CAVITY) ON SHIFT START-UP AND 8 UNITS (2 P/CAVITY) EVERY FOUR HOURS. FINAL INSPECTION AS PER BDM0180 WAS PERFORMED ON 05 AUG 2016 FOR REQUIRED TESTING AS PER PRODUCT SPECIFICATION SP1789. INSPECTION PERFORMED BY QUALITY INSPECTOR INCLUDED VISUAL, DIMENSIONAL AND FUNCTIONAL TESTING. SPECIFIC FOR THE DETECTION OF DEFECT CANNULA USING 0.65% AQL LII ON 500 SAMPLES. MOREOVER, FUNCTIONAL PULL FORCE TEST ON NEEDLE WAS PERFORMED ON 20 SAMPLES USING A SINGLE S3 LEVEL, AQL 0.40% WITH ACCEPTABLE RESULTS. NO NCMR NOR MACHINE INTERVENTIONS WERE REPORTED BY THIS LOT. PREVENTIVE MAINTENANCE ON THE TIC# 2 MACHINE WAS CONDUCTED AS PER SCHEDULE. REVIEW OF INSTRUMENT CALIBRATIONS AS PER INSPECTION RECORDS WAS CONDUCTED AND THEY WERE CALIBRATED WITHIN THEIR CALIBRATION DUE DATES. SUMMARY: DEVICE HISTORY RECORD REVIEW FOR THE LOT 6216954 WAS PERFORMED AND NO NON-CONFORMANCES IMPACTING POTENTIAL SPINAL NEEDLE CANNULA BREAKAGE WERE OBSERVED. ALL THE INSPECTIONS WERE PERFORMED AS ESTABLISHED PER PROCEDURES WITH SATISFACTORY RESULTS. THUS, INCOMING INSPECTION WERE IN COMPLIANCE. THE DRAWING AND SPECIFICATION FOR THE CANNULA 31940 AND STYLET 31334 WERE VERIFIED AND NO CHANGES IN THE CANNULA/STYLET MATERIAL WERE PERFORMED. NO POSSIBLE CAUSE HAS BEEN IDENTIFIED FOR THIS COMPLAINT RELATED TO JUNCOS MANUFACTURING PROCESS. THE SAMPLES RECEIVED WERE EVALUATED AND NO DEFECTS THAT MAY HAVE CAUSED THE BREAKAGE WERE FOUND: ANY OF THE SAMPLES HAS NICKS OR OTHER DAMAGED IN THE SURFACE WHICH MAY CAUSE THE BREAKAGE. IT SEEMS LIKELY THAT THE BREAKAGE OCCURS DUE TO REPEATED REPOSITIONING. AS IT IS EXPLAINED IN THE IFU (DGP158), THIS PRACTICE MAY INCREASE THE RISK OF NEEDLE BREAKAGE AND THEREFORE IT IS NOT RECOMMENDED. IT SEEMS LIKELY THAT THE REPEATED REPOSITIONING ALSO CAUSED THE NEEDLE TO BEND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WHITACRE 27GA 3-1/2IN EXPERIENCED CANNULA BREAKAGE IN THE SPINE OF PATIENT DURING EPIDURAL ANAESTHESIA

    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 THE WHITACRE 27GA 3-1/2IN EXPERIENCED CANNULA BREAKAGE IN THE SPINE OF PATIENT DURING EPIDURAL ANAESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94891 WHITACRE 27GA 3-1/2IN NEEDLE FMI BECTON DICKINSON, S.A. 1707008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other