BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPI NOVOQU2/0 70 DS24,2X0 90 HRC43(M)DDP

    MDR report key: 17030045 · Received May 31, 2023

    Report

    Report Number
    3003639970-2023-00169
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Report Date
    May 31, 2023
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 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. UNDER PMA/510(K) NUMBER: K170661. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 2,280 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED THREE CLOSED SAMPLES FOR ANALYSIS. THIS PRODUCT CODE CONTAINS 1 SUTURE OF NOVOSYN QUICK USP 2/0 70CM DS24 AND 2 SUTURES OF NOVOSYN QUICK USP 0 90CM HRC43. ACCORDING TO THE INFORMATION RECEIVED, IT OCCURRED WITH THE DS24 NEEDLE. THE DS24 NEEDLES OF THE SAMPLES RECEIVED HAVE BEEN TESTED FOR BENDING STRENGTH AND THE RESULTS FULFILL PRODUCT SPECIFICATIONS: 16.11 NXCM IN MINIMUM (MINIMUM BENDING STRENGTH SPECIFICATION FOR THIS NEEDLE: > 13.6 NXCM). REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. NEEDLE BENDING STRENGTH RESULTS DURING PRODUCTION OF THE TWO DS24 NEEDLE RAW MATERIAL BATCHES USED IN THIS PRODUCT WERE 16.54 NXCM AND 16.28 NXCM IN MINIMUM AND FULFILLED SPECIFICATIONS. AS STATED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT, CARE SHOULD BE TAKEN TO AVOID DAMAGE WHEN HANDLING SURGICAL NEEDLES. GRASP THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE ATTACHMENT END TO THE POINT. GRASPING IN THE POINT AREA COULD IMPAIR THE PENETRATION PERFORMANCE AND CAUSE FRACTURE OF THE NEEDLE. GRASPING AT THE BUTT OR ATTACHMENT END COULD CAUSE BENDING OR BREAKAGE. RESHAPING NEEDLES MAY CAUSE THEM TO LOSE STRENGTH AND BE LESS RESISTANT TO BENDING AND BREAKING. ADDITIONALLY, REVIEWED THE COMPLAINT HISTORY RECORD, THERE ARE NO OTHER COMPLAINTS REGARDING THIS ISSUE IN ANY OF THE OTHER PRODUCTS MANUFACTURED WITH THE SAME NEEDLE RAW MATERIAL BATCHES THAT HAVE BEEN USED IN THIS PRODUCT. ACCORDING TO THE RESULTS OF THE TEST REALIZED TO THE CLOSED SAMPLES RECEIVED FROM THE CUSTOMER AND THE BATCH MANUFACTURING RECORDS REVIEW, THE PRODUCTS COMPLY WITH OUR SPECIFICATIONS; THEREFORE, WE DO NOT SEE ANY MANUFACTURING FAULT OR MATERIAL DEFECT THAT COULD HAVE CAUSED THE INCIDENCE. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH EPI NOVOSYN QUICK SUTURE. THE CLIENT REPORTED THAT DURING AN EPISIOTOMY, ONE NEEDLE OF OUR EPISIOTOMY SET BROKE OFF SHORTLY AFTER THE NEEDLE THREAD TRANSITION. IT TOOK BETWEEN 30-45 MIN TO RECOVER THE REMAINING NEEDLE. HOWEVER, THERE WAS NO DAMAGE TO THE PATIENT. ALSO NO ADDITIONAL CUT. ADDITIONAL INFORMATION RECEIVED: PERINEAL TEAR POST-PARTUM. PATIENT OUTCOME: INCONSPICUOUS. TYPE OF OPERATION: OBSTETRIC PERINEAL SUTURE. TISSUE: VAGINA, PERINEUM. SUTURE TECHNIQUE EMPLOYED: SINGLE-HEADED SEAM. IT OCCURRED DURING THE LAST SUTURE. THE VAGINA AND PERINEUM WERE TREATED AS FAR AS POSSIBLE; THEN, DURING THE LAST STITCH, THE BROKEN-OFF NEEDLE SANK DIRECTLY INTO THE TISSUE. THE BROKEN OFF PART COULD BE RECOVERED AFTER A LONG SEARCH WITHOUT FURTHER TRAUMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557399 EPI NOVOQU2/0 70 DS24,2X0 90 HRC43(M)DDP SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A. B3046911 122393

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female