BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE BL 3-0 90 CM CC-30(2)

    MDR report key: 11373774 · Received February 24, 2021

    Report

    Report Number
    2210968-2021-01758
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    January 1, 2021
    Report Date
    January 21, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT TO THE FDA: 4/5/2021 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. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: W8849 PACKAGE CODE - STITCHING WITH A MICRO-SHARPENED POINT (CC NEEDLE) INDICATED BY THE WORDS ON THE LABEL - STABBING WITH A MICRO-SHARPENED POINT DOSSIER - NOT IN DOSSIER TECHNICAL DOCS - STABBING WITH SHARPENED MICROPOINT ATTRIBUTE MODELS - TAPERCUT IN THE CATALOG - STABBING PRICE LIST - PROLENE BLUE M2 (3/0) 90CM TWO NEEDLES CC-30 (B)(4) DATE SENT TO THE FDA: 4/5/2021 CORRECTED INFORMATION: D3

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 4/20/2021 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. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: CORRECT ALERT DATA IS (B)(6) 2021, (B)(4). DATE SENT TO THE FDA: 4/20/2021. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER PJJ811 / XCW884919, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE PRODUCT WAS NOT RETURNED TO ETHICON INC FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THE PICTURE RECEIVED. VISUAL ANALYSIS OF THE PICTURES RECEIVED DETERMINED THAT A SEALED BOX RELABELED WITH A RUSSIAN LABEL OF THE PRODUCT CODE W8849 COULD BE OBSERVED. UPON FURTHER INVESTIGATION WAS DETERMINED THAT THE PRODUCT CODE W8844 BELONGS TO 3-0¿ PROLENE SUTURE DOUBLE ARMED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: COULD YOU PLEASE SPECIFY ABOUT THE LABELING ISSUE BEING REPORTED? COULD YOU PLEASE PROVIDE MORE DETAILS ABOUT" THE DISCREPANCY BETWEEN THE DESCRIPTION IN THE CATALOG AND THE INFORMATION ON THE LABELS". FOR INCONSISTENCY - IN OUR APPEAL WE INDICATED: "ON THE LABELS ON THE PACKAGING OF THE ABOVE PRODUCTS, CAT. NO. W8704. W8843. W8721. W8844. W8849. Z1712H. Z1711H. THE STABBING NEEDLE IS INDICATED, WHILE THE DESCRIPTION IN THE CATALOG IS THE STITCHING NEEDLE. " COULD YOU PLEASE PROVIDE THE EVENT DATE?- THE DATE OF WHAT EVENT DO YOU MEAN? SHIPMENTS TO CLINICS? THEY HAVE NOT HAPPENED YET, BECAUSE DO NOT ACCEPT PRODUCTS WITH SUCH STICKERS. OUR LETTER WITH A REQUEST FOR CLARIFICATION - DATED 01/21/2021. COULD YOU PLEASE PROVIDE THE LOT NUMBERS OF THE PRODUCTS?- BATCH NUMBERS: W8704- SERIES PEB979, PEB813. W8843- PCJ744, PJJ992 SERIES. W8721- PEH408 SERIES. W8844- QDBEDR SERIES. W8849- PJJ811 SERIES. Z1712H- QDMHTM SERIES. Z1711H- QHMKJT SERIES. COULD YOU PLEASE CONFIRM THE DEVICE'S AVAILABILITY FOR RETURN?- THE GOODS ARE IN OUR WAREHOUSE IN (B)(4), AVAILABLE FOR RETURN. NOTE: EVENTS WERE SUBMITTED VIA 2210968-2021-01752, 2210968-2021-01754, 2210968-2021-01755, 2210968-2021-01756, 2210968-2021-01759, 2210968-2021-01763, 2210968-2021-01764 AND 2210968-2021-01765.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUTURE WHICH WAS FOR DELIVERY TO THE HEALTHCARE FACILITY HAS INCORRECT LABELS IN (B)(6). IT WAS REPORTED THAT THERE WAS A THE DISCREPANCY BETWEEN THE DESCRIPTION IN THE CATALOG AND THE INFORMATION ON THE LABELS: STABBING NEEDLE WAS INDICATED, WHILE THE DESCRIPTION IN THE CATALOG HAS THE STITCHING NEEDLE. THERE WERE NO PATIENT INVOLVEMENT OR PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271216 PROLENE BL 3-0 90 CM CC-30(2) SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. PJJ811

    Patients

    Seq Age Sex Outcome Treatment
    1