BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8728195 · Received June 24, 2019

    Report

    Report Number
    3003152976-2019-00414
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    May 24, 2019
    Report Date
    August 9, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS AND ONE SAMPLE WERE RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE BARREL IS DAMAGED AT THE 20ML MARKING. WHEN THE STOPPER MOVES ACROSS THIS POINT IT BECOMES DISTORTED, RESULTING IN THE LEAK REPORTED. A DEVICE HISTORY WAS PERFORMED AND FOUND NO NO-CONFORMANCES RELATED TO THE REPORTED ISSUE DURING PRODUCTION OF BATCH 1902236. TEN RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED AND NO LEAK WAS OBSERVED. WHILE A DIRECT ISSUE COULD NOT BE IDENTIFIED, THE DAMAGE OBSERVED WAS CONSISTENT WITH THE TRANSFER WHEELS USED TO MOVE PRODUCT WITHIN THE MANUFACTURING LINE. IT IS LIKELY THE PRODUCT BECAME JAMMED IN THE EQUIPMENT, RESULTING IN THE DAMAGE REPORTED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "UP TO 8.5 ML" OF 1% PROPOFOL WAS NOT DELIVERED TO THE PATIENT DUE TO LEAKAGE PAST THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PLUNGER DURING USE. THE DEVICE HAD REPORTEDLY BEEN INDUCED WITH FENTANYL 100MCG, THEN REMIFENTANIL 50MCG/ML TCI TARGET 3NG/ML FOR ANESTHESIA, AND THE PATIENT WAS GIVEN ATRACURIUM BEFORE BEING INTUBATED, WITH BIS, EYE LUBE TAPES, PADS, AND A TEMPORARY PROBE APPLIED BEFOREHAND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A 50ML BD PLASTIPAK SYRINGE (ALMOST CERTAINLY BATCH 1902236) ALLOWED 1% PROPOFOL TO PASS THE BLACK PLUNGER AND NOT REACH THE PATIENT. THIS WAS FOUND TO OCCUR WITH BETWEEN 21ML AND 12.8ML REMAINING IN THE SYRINGE, RESULTING IN THE PATIENT NOT RECEIVING UP TO 8.5ML OF DRUG. IT IS UNLIKELY THAT THE PATIENT WAS AWARE (NOT KNOWN AT TIME OF WRITING AS PATIENT IS STILL ANAESTHETISED). SYRINGE WAS DAMAGED EITHER IN MANUFACTURE, TRANSPORT OR STORAGE. PATIENT: 52 YEAR OLD PATIENT, 85KG FOR BILATERAL MASTECTOMY AND DIEP FREE FLAP RECONSTRUCTIONS. NO COMORBIDITIES APART FROM BREAST CANCER. ANAESTHETIC: 20G CANNULA SITED IN DOSUM OF HAND. INDUCED WITH FENTANYL 100MCG, THEN REMIFENTANIL 50MCG/ML TCI TARGET 3NG/ML, PROPOFOL 5NG/ML. APPEARED SLEEPY. ATRACURIUM GIVEN. ONCE EFFECTIVE INTUBATED USING BOUGIE. BIS, EYE LUBE TAPES AND PADS APPLIED, TEMP PROBE. TRIED TO SITE ART LINE - NIBP SHOWED BP 210/ HR 85. SOON AFTER NOTICED SMALL AREA OF WHITE FLUID ON THE FLOOR DRIPPING FROM THE OPEN END OF THE SYRINGE BARREL. SUBSEQUENTLY RECREATED BY DRIPPING PROPOFOL INTO SYRINGE BARREL IN A PUMP, AND THOUGHT TO BE BETWEEN 3-4.5ML TOTAL LOSS.

    Additional Manufacturer Narrative · 1

    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 "UP TO 8.5 ML" OF 1% PROPOFOL WAS NOT DELIVERED TO THE PATIENT DUE TO LEAKAGE PAST THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PLUNGER DURING USE. THE DEVICE HAD REPORTEDLY BEEN INDUCED WITH FENTANYL 100MCG, THEN REMIFENTANIL 50MCG/ML TCI TARGET 3NG/ML FOR ANESTHESIA, AND THE PATIENT WAS GIVEN ATRACURIUM BEFORE BEING INTUBATED, WITH BIS, EYE LUBE TAPES, PADS, AND A TEMPORARY PROBE APPLIED BEFOREHAND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A 50ML BD PLASTIPAK SYRINGE (ALMOST CERTAINLY BATCH 1902236) ALLOWED 1% PROPOFOL TO PASS THE BLACK PLUNGER AND NOT REACH THE PATIENT. THIS WAS FOUND TO OCCUR WITH BETWEEN 21ML AND 12.8ML REMAINING IN THE SYRINGE, RESULTING IN THE PATIENT NOT RECEIVING UP TO 8.5ML OF DRUG. IT IS UNLIKELY THAT THE PATIENT WAS AWARE (NOT KNOWN AT TIME OF WRITING AS PATIENT IS STILL ANAESTHETISED). SYRINGE WAS DAMAGED EITHER IN MANUFACTURE, TRANSPORT OR STORAGE. PATIENT: (B)(6) YEAR OLD PATIENT, (B)(6) FOR BILATERAL MASTECTOMY AND DIEP FREE FLAP RECONSTRUCTIONS. NO COMORBIDITIES APART FROM BREAST CANCER. ANAESTHETIC: 20G CANNULA SITED IN DOSUM OF HAND. INDUCED WITH FENTANYL 100MCG, THEN REMIFENTANIL 50MCG/ML TCI TARGET 3NG/ML, PROPOFOL 5NG/ML. APPEARED SLEEPY. ATRACURIUM GIVEN. ONCE EFFECTIVE INTUBATED USING BOUGIE. BIS, EYE LUBE TAPES AND PADS APPLIED, TEMP PROBE. TRIED TO SITE ART LINE - NIBP SHOWED BP 210/ HR 85. SOON AFTER NOTICED SMALL AREA OF WHITE FLUID ON THE FLOOR DRIPPING FROM THE OPEN END OF THE SYRINGE BARREL. SUBSEQUENTLY RECREATED BY DRIPPING PROPOFOL INTO SYRINGE BARREL IN A PUMP, AND THOUGHT TO BE BETWEEN 3-4.5ML TOTAL LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522704 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1902236

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other