BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN QUICK UNDY 3/0(2)70CM DSMP19MDDP

    MDR report key: 8941410 · Received August 28, 2019

    Report

    Report Number
    3003639970-2019-00618
    Event Type
    Malfunction
    Date Received
    August 28, 2019
    Date of Event
    August 3, 2019
    Report Date
    September 9, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING EVALUATION: ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINT OF THIS CODE BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 13 UNOPENED POUCHES. WE HAVE CHECKED ALL SAMPLES RECEIVE AND ALL PACKS HAVE ONLY ONE NEEDLE INSIDE THE PACK AS THE PRODUCT DESCRIPTION. FURTHERMORE, WITHOUT DEFECTIVE SAMPLES OR PICTURES SHOWING THE DEFECT A PROPER ANALYSIS CAN NOT BE PERFORMED. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED.

    Additional Manufacturer Narrative · 1

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K122734. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE NOVOSYN SUTURE. DURING AN OPEN APPENDECTOMY, IT WAS NOTED THAT THE PACKET CONTAINED 2 NEEDLES INSTEAD OF 1. THIS CREATED SOME CONFUSION BUT THE SHARPS AND SPONGE COUNTS WERE CORRECTED; THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733802 NOVOSYN QUICK UNDY 3/0(2)70CM DSMP19MDDP SYNTHETIC ABSORBABLE BRAIDED GAM B.BRAUN SURGICAL SA C3046530 118464

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR