BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHIBOND WHT 3.0M 75CM W/2 NDL

    MDR report key: 7958094 · Received October 11, 2018

    Report

    Report Number
    2210968-2018-76479
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 18, 2018
    Report Date
    September 18, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 12/21/2018. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. IN ADDITION TO INITIALLY REPORTED LABEL PACKAGE INFORMATION, THE SUTURES CONTAINED IN THE PACKAGE WERE RETURNED AND LABELED WITH THE FOLLOWING PRODUCT INFORMATION: BRAND NAME - POLYPROPYLENE SUTURE. PROCODE - GAW. CATALOG - EH8014. BATCH MBM194 MFG DATE: 02/02/2018, EXP DATE: 01/31/2023. EVALUATION: REPRESENTATIVE SAMPLES RETURNED TO SUPPORT INVESTIGATION OF MULTIPLE DEVICE ISSUES CAPTURED IN REPORTS 2210968-2018-76465, 2210968-2018-76468, 2210968-2018-76471, 2210968-2018-76472, 2210968-2018-76473, AND 2210968-2018-76479. ANALYSIS RESULTS HAVE BEEN INCLUDED IN FOLLOW-UP REPORTS FOR EACH. SIX SEALED BOXES OF PRODUCT WERE RECEIVED FOR EVALUATION. DURING THE VISUAL INSPECTION OF THE SIX BOXES THE INCORRECT COLOR CODING COULD BE OBSERVED. THE BOXES WERE OPENED, AND EACH BOX CONTAINS 36 SAMPLES OF ANOTHER PRODUCT. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. PER THE CONDITION OF THE SAMPLE RECEIVED THE ASSIGNABLE CAUSE OF THE PACKAGING LABELING IDENTIFICATION IS A MANUFACTURING PRODUCT DEFECT.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # PC-(B)(4). ATTEMPTS ARE BEING MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ALL INFORMATION REQUESTED WERE ALREADY PROVIDED TO THE COMPLAINT SUBMISSION: PLEASE CLARIFY THE ISSUE "6 BOXES HAD WRONG PROLENE COLOR CODING": - DID THE 6 BOXES HAVE A WRONG COLOR? NO PLEASE REFER TO THE DESCRIPTION - DID THE ENVELOPES INSIDE THESE 3 BOXES HAVE A WRONG COLOR?PLEASE REFER TO THE DESCRIPTION DO YOU HAVE PICTURES OF THE BOXES? ALREADY ATTACHED

    Additional Manufacturer Narrative · 1

    PC-(B)(4). THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. THERE WAS NO SAMPLE RECEIVED FOR ANALYSIS. ONLY PICTURES OF THE SAMPLE WERE RECEIVED FOR ANALYSIS. UPON VISUAL INSPECTION OF THE PICTURE, SIX BOXES OF ETHIBOND EXCEL FOR PRODUCT CODE (B)(4) LOT# MBM232 WITH AN INCORRECT COLOR CODING COULD BE OBSERVED. HOWEVER, THE SAMPLES WERE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOXES HAD THE WRONG PROLENE COLOR CODING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799326 ETHIBOND WHT 3.0M 75CM W/2 NDL SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC. MBM232

    Patients

    Seq Age Sex Outcome Treatment
    1