PROLENE SUT 30IN(75CM) 6-0 BLU
Report
- Report Number
- 2210968-2023-02314
- Event Type
- Malfunction
- Date Received
- April 4, 2023
- Date of Event
- February 1, 2023
- Report Date
- June 8, 2023
- Manufacturer
- ETHICON INC.
- Product Code
- GAW
- PMA / PMN Number
- K133356
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT COMPLAINT #(B)(4). ADDITIONAL INFORMATION: H6: COMPONENT CODE: G07002 - DEVICE NOT RETURNED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NO FURTHER INFORMATION CAN BE PROVIDED. NOTE: EVENTS REPORTED ON: MW# 2210968-2023-02316. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.
PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 6/1/2023. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: I MADE A MATERIOVIGILANCE DECLARATION ON (B)(6) 2023 FOR THE SABERC BATCH. THE OFFENDING MATERIAL HAS BEEN SENT TO YOU IN ACCORDANCE WITH YOUR INSTRUCTIONS. THE DECLARATION THAT YOU SENT ME AS AN ATTACHMENT WAS MADE IN (B)(6) 2022 BY THE MATERIOVIGILANCE CORRESPONDENT, MR. GIRAUD, AND CONCERNS THE SGBCAA BATCH. NOT BEING AWARE OF THE DECEMBER REPORT, I CANNOT CONFIRM WHETHER THE SHIPMENT OF THE DEFECTIVE EQUIPMENT HAS BEEN MADE. THE FOLLOWING ADDITIONAL INFORMATION WAS REQUESTED: THE FOLLOWING INFORMATION WAS RECEIVED REGARDING THE RETURNED PRODUCT FOR LOT SGBCAA: THE DECLARATION THAT YOU SENT ME AS AN ATTACHMENT WAS MADE IN (B)(6) 2022 BY THE MATERIOVIGILANCE CORRESPONDENT, MR. GIRAUD, AND CONCERNS THE SGBCAA BATCH.PLEASE CONFIRM IF LOT SGBCAA BELONGS TO THE 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. RELATED REPORTS: 2210968-2023-02314 & 2210968-2023-02316.
PRODUCT COMPLAINT #: (B)(4). DATE SENT TO THE FDA: 5/10/2023. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. A DEVICE HAS BEEN RECEIVED FOR PRODUCT CODE EH7474H, LOT SGBCAA; HOWEVER IT IS UNKNOWN IF THE PRODUCT BELONGS TO THIS COMPLAINT. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. OUR FAILURE ANALYSIS LAB RECEIVED THE ADDITIONAL PRODUCT WITH REFERENCE TO THIS COMPLAINT, THE FOLLOWING PRODUCT WAS RECEIVED: -PRODUCT CODE EH7474H; LOT SGBCAA THIS COMPLAINT IS FOR PRODUCT CODE PRODUCT CODE: EH7474H, LOT SABERC. 1. COULD YOU PLEASE CLARIFY IF THE ADDITIONAL DEVICE BELONG TO THIS COMPLAINT? 1A. IF YES, DID A DEVICE MALFUNCTION OCCUR DURING THE SAME PROCEDURE? 2. IF NOT, COULD YOU PLEASE CLARIFY IF THE ADDITIONAL RECEIVED PRODUCT BELONGS TO A DIFFERENT COMPLAINT? IF SO, CAN YOU PLEASE PROVIDE THE COMPLAINT NUMBER. 3. IF THE DEVICE WAS NOT REPORTED BEFORE, PLEASE PROVIDE MORE DETAILS OF DEVICE MALFUNCTION. 4. IF THE PRODUCT DOESN¿T BELONG TO ANY COMPLAINT, PLEASE LET US KNOW SO WE CAN DISCARD IT OR ADVISE IF THE PRODUCT IS REQUIRED TO BE RETURNED. 5. IF YOU HAVE THE CORRECT COMPLAINT PRODUCT IN YOUR POSSESSION, PLEASE FORWARD THE PRODUCT TO ETHICON AS SOON AS POSSIBLE. IF YOU HAVE ALREADY SENT THE PRODUCT TO ETHICON, PLEASE REPLY TO [email protected] WITH THE UPS, DHL OR FEDEX TRACKER NUMBER. 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. RELATED REPORTS: 2210968-2023-02316. PRODUCT COMPLAINT #: (B)(4). DATE SENT TO THE FDA: 5/10/2023. 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.
PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 6/8/2023. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: THE FOLLOWING INFORMATION WAS RECEIVED REGARDING THE RETURNED PRODUCT FOR LOT SGBCAA: THE DECLARATION THAT YOU SENT ME AS AN ATTACHMENT WAS MADE IN DECEMBER 2022 BY THE MATERIOVIGILANCE CORRESPONDENT, MR. GIRAUD, AND CONCERNS THE SGBCAA BATCH. PLEASE CONFIRM IF LOT SGBCAA BELONGS TO THE COMPLAINT (B)(4). THE CONTACT FOR THIS COMPLAINT CANNOT CONFIRM IF THESE RECEIVED SAMPLES ARE RELATED TO THE COMPLAINT (B)(4). H3 PHOTO INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT TWELVE PACKETS THAT PERTAINS TO PRODUCT CODE EH7474H, LOT SGBCAA WERE RETURNED FOR ANALYSIS. UPON INITIAL INSPECTION, OF THE SAMPLES, NO EXTERNAL DAMAGES WERE OBSERVED ON THE PACKET. IN ORDER TO EVALUATE THE CONDITIONS OF THE RETURNED SAMPLES, THE PACKETS WERE OPENED, AND NO DEFECTS WERE DETECTED. THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND TO DETECT ANY ISSUE RELATED NO DEFECTS WERE OBSERVED DURING EVALUATION. A FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT, AND THE PULL FORCE RESULTS WERE ABOVE THE MINIMUM REQUIREMENTS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH BATCH IS RANDOMLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. 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. RELATED REPORTS: 2210968-2023-02314 & 2210968-2023-02316. PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 6/8/2023. CORRECTED INFORMATION: D4, H4 - THE ACTUAL DEVICE LOT NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE POSSIBLE LOT NUMBERS ARE REPORTED AS FOLLOWS: BATCH SABERC, BATCH SGBCAA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH SABERC, XNEH7474H19 AND NO NON-CONFORMANCES WERE IDENTIFIED. MFG. DATE - 1/27/2022, EXP. DATE - 12/31/2026. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH SGBCAA , XNEH7474H19 AND NO NON-CONFORMANCES WERE IDENTIFIED. MFG. DATE - 6/9/2022, EXP. DATE - 5/31/2027. 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.
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLES PULLED OFF FROM THE THREAD. NO REPORTED PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 391722 | PROLENE SUT 30IN(75CM) 6-0 BLU | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | GAW | ETHICON INC. | SABERC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |