BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMB TAPE WHT 2X18INX1/8IN NON NDL

    MDR report key: 17836122 · Received September 28, 2023

    Report

    Report Number
    2210968-2023-07120
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Report Date
    September 28, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    EXM
    UDI-DI
    10705031051034
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: QUESTION NO. 1: PROVIDE PATIENT DEMOGRAPHIC INFORMATION. CASE 2: SEX F; AGE 39 WEEKS; WEIGHT 3.88 KG QUESTIONS NO. 2: DESCRIBE ANY MEDICAL/SURGICAL INTERVENTIONS REQUIRED FOR THIS SUTURING EVENT, INCLUDING DATES AND RESULTS. - THE THREE (3) CASES WERE BY CESAREAN SECTION, THE HILADILLO TAPE WAS USED TO LIGATE THE UMBILICAL CORD, QUESTION NO. 3: DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ABNORMALITY BEFORE, DURING, AFTER SUTURE PLACEMENT, OR DURING ANY REOPERATION? - ONLY WHEN USING THE YARN TAPE ON THE UMBILICAL CORD DOES IT CUT CAUSING BLEEDING. LIKEWISE, THE KNOT IS EASILY RELEASED. QUESTIONS NO. 4: HOW WAS THE SUTURE ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)? - IT IS UNKNOWN. QUESTIONS NO. 5: WHAT WAS THE VOLUME OF BLOOD LOSS? - IT IS UNKNOWN QUESTION NO. 6: HOW DID THE BLEEDING STOP? - QUESTIONS NO. 7: OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? - QUESTION NO. 8: WHAT IS THE DOCTOR'S OPINION AS TO THE ETIOLOGY OR CONTRIBUTING FACTORS TO THIS EVENT? - A STRANGER QUESTION NO. 9: WHAT IS THE PATIENT'S CURRENT STATUS? - THE CASE WAS DISCHARGED WITHOUT KNOWN SEQUELAE. THE REPORTED SITUATIONS REVOLVE AROUND FAILURE TO TIE THE UMBILICAL CORDS WITH SUBSEQUENT BLEEDING IN THE UMBILICAL CORD. FIELD INVESTIGATIONS WERE CARRIED OUT, WHICH INCLUDED REVIEW OF CLINICAL RECORDS, BOTH PAPER AND ELECTRONIC. DURING THE INVESTIGATIONS,, NO RECORD OF FINDINGS, ANOMALIES, INTERVENTIONS, OR FOLLOW-UPS RELATED TO THE REPORTED SITUATION WAS FOUND. DEVICE HISTORY REVIEW - A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER AL6753/XYU10T, AND NO NON CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. MANUFACTURED DATE: 22.01.2019 EXPIRED DATE: 31.12.2023

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEWBORN UNDERWENT UMBILICAL CORD TYING ON AN UNKNOWN DATE AN SUTURE WAS USED. WHEN USING THE TAPE ON THE UMBILICAL CORD, IT CUTS CAUSING BLEEDING FROM IT. LIKE THE KNOT IS BEING RELEASED EASILY AND IT LEAVES THE CORD AND BEGAN TO BLEED. DESPITE MAKING 3 KNOTS OF THE HILADILLO TO CUT THE UMBILICAL CORD, THE PATIENT HAS ABUNDANT BLEEDING FROM IT. IT SHOULD BE NOTED THAT THESE PROCEDURES OF LIGATION AND TYING OF THE UMBILICAL CORD, IN THESE CASES, WERE PERFORMED BY THE PEDIATRICIANS AND RESIDENTS OF NEONATOLOGY, IN THE NEWBORN. ADDITIONAL INFORMATION WAS REQUESTED. THE CASE WAS DISCHARGED WITHOUT KNOWN SEQUELAE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2098523 UMB TAPE WHT 2X18INX1/8IN NON NDL CLASS I DEVICE - EXEMPT EXM ETHICON INC. AL6753 10705031051034

    Patients

    Seq Age Sex Outcome Treatment
    1 Female