BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿

    MDR report key: 6869173 · Received September 15, 2017

    Report

    Report Number
    1213809-2017-00117
    Event Type
    Malfunction
    Date Received
    September 15, 2017
    Date of Event
    August 22, 2017
    Report Date
    December 5, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. NO SAMPLE, NO LOT NUMBER INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    DHR REVIEW FOR BATCH 7031978 (P/N 309658): MANUFACTURING DATES: 02/18/2017 ¿ 2/19/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. ADJUSTMENTS WERE RECORDED PERFORMED ON BOTH DAYS TO THE MARKER SYSTEM DURING THE MANUFACTURE OF THIS BATCH. PRODUCT WAS INSPECTED AFTER ADJUSTMENTS WITH NO DEFECTS NOTED. BATCH 7031978 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: A TOTAL OF 19 SAMPLES IN SEALED BLISTER PACKS WERE RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH #7031978 (P/N 309658). THE SAMPLES WERE VISUALLY EVALUATED. THE SAMPLES HAVE VARYING DEGREES OF MISSING PRINT, WITH SOME SAMPLES HAVING AN ADDITION OF INK RINGS AS WELL. THE AMOUNT OF MISSING PRINT IS SEVERE, WITH ENTIRE GRAD LINES MISSING AND IN SOME CASES MOST OF THE SCALE MISSING. ADDITIONALLY, THREE SAMPLES FROM BATCH #7150703, ONE SAMPLE FROM BATCH #6307974, ONE FROM BATCH #7001973 AND ONE FROM BATCH #7150704 WERE RECEIVED IN A SEPARATE BAG AND HAD NO PRINT DEFECTS. IT IS UNCLEAR WHY THESE SAMPLES WERE RETURNED. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: BASED ON THE SAMPLE EVALUATION: CONFIRMED: BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. ROOT CAUSE DESCRIPTION: IT IS POSSIBLE THAT DURING ADJUSTMENTS BEING PERFORMED ON THE MARKER THE PRODUCT WAS NOT PROPERLY CONTAINED AND ENDED UP BEING MIXED WITH THE GOOD PRODUCT. RATIONALE: BASED ON THE SEVERITY ASSIGNED TO THIS COMPLAINT AND THE RESULTS OF THE COMPLAINT LOT HISTORY CHECK, CAPA IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT IS REPORTED THAT MANY OF THE BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿ (LOT 7031978) ARRIVED WITH SCALE MARKING ISSUES. SOME WITHOUT SCALE LINES AND SOME WITH SMUDGES. FOUND BEFORE USE. NO SERIOUS INJURIES OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647757 BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿ HYPODERMIC SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other