BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD UD 36IN 1 S/A CTB-1

    MDR report key: 14876792 · Received June 30, 2022

    Report

    Report Number
    2210968-2022-05003
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    June 2, 2022
    Report Date
    August 11, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031044081
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEVICE NOT RETURNED 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. ATTEMPTS HAVE BEEN 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT WAS THE SIZE OF THE NEEDLE USED? WAS MORE THAN HALF THE NEEDLE RETAINED IN THE PATIENT? WHERE WAS THE NEEDLE RETAINED; IN WHAT STRUCTURE? PROCEDURE NAME? A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. PHOTO ANALYSIS: THIS IS AN ANALYSIS OF TWO PHOTOS SUBMITTED FOR REVIEW. DURING THE VISUAL ANALYSIS THE FOLLOWING WAS OBSERVED: THE PHOTOS SHOW A PLASTIC CONTAINER WITH A BROKEN NEEDLE AND A PAPER LID OF PRODUCT CODE JB947. BASED ON THE PHOTO REVIEW, THE EVENT DESCRIBE IS CONFIRMED, HOWEVER NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT. BECAUSE THE INSTRUMENT WAS NOT RETURNED OUR EVALUATION IS LIMITED. WE VALUE THE OPPORTUNITY TO FULLY ANALYZE THE INSTRUMENT UPON ITS RETURN. AS PART OF QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. WE VALUE YOUR ASSISTANCE IN PROVIDING US AN OPPORTUNITY TO EVALUATE THE REPORTED EVENT AS ALL INFORMATION REPORTED TO OUR COMPANY IS CRITICAL TO OUR CONTINUOUS IMPROVEMENT EFFORTS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 8/11/2022 H3 INVESTIGATIONAL SUMMARY: A FAILED SUTURE NEEDLE WAS SUBMITTED FRACTOGRAPHIC EVALUATION. THE COMPONENT WAS IDENTIFIED AS PRODUCT CODE JB947. IT WAS REQUESTED THAT ASSESS THE FRACTURE MODE OF THE FAILURE. A FRACTURE WAS OBSERVED IN THE BODY OF THE NEEDLE. THE NEEDLE WAS RECEIVED IN TWO PIECES, ONLY ONE OF THE MATING FRACTURE SURFACES WAS EXAMINED FOR THIS EVALUATION. A SCANNING ELECTRON MICROSCOPE WAS USED TO EXAMINE THE FRACTURE SURFACES AND SURROUNDING AREA OF THE NEEDLE. THE FRACTURE SURFACES WERE EXAMINED IN MULTIPLE LOCATIONS TO DETERMINE THE FRACTURE MODE. THE EVALUATION REVEALED THE FRACTURE WAS COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE FRACTURE MODE. MECHANICAL DAMAGE AND MACROSCOPIC PLASTIC DEFORMATION OBSERVED COINCIDENTAL TO THE FRACTURE PROVIDE ADDITIONAL EVIDENCE THAT THE FAILURE WAS INDUCED BY MECHANICAL DEFORMATION LEADING TO DUCTILE OVERLOAD. THIS WAS A DUCTILE FRACTURE. THE EVIDENCE OF THIS EXAMINATION INDICATES THAT THE BREAKAGE OCCURRED FROM MECHANICAL DEFORMATION, INDENTS AND SCRATCHES, DUE TO GRIPPING, BENDING AND OVERSTRESSING OF THE NEEDLE. THERE IS NO EVIDENCE OF ANY MATERIAL FLAW THAT WOULD CAUSE PREMATURE FAILURE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE FROM THE SUTURE HAS BROKEN IN HALF WHILE SUTURING. REMOVED FROM STERILE FIELD ONCE SURGICAL COUNT COMPLETED, PLACED IN SPECIMEN JAR FOR INVESTIGATION, XRAY WAS NOT REQUIRED AS NO LOST BITS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057944 VCL CT BRD UD 36IN 1 S/A CTB-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. JB947 RJMJMH 10705031044081

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown