NON ABSORBABLE SURGICAL SUTURE
Report
- Report Number
- 2210968-2022-05313
- Event Type
- Malfunction
- Date Received
- July 11, 2022
- Date of Event
- June 13, 2022
- Report Date
- August 30, 2022
- Manufacturer
- ETHICON INC.
- Product Code
- GAP
- PMA / PMN Number
- K946173
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(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. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: "WAS THERE ANY ADVERSE CONSEQUENCE ASSOCIATED WITH THE PATIENT? PLEASE PROVIDE MORE DETAILS. NO. PLEASE PROVIDE THE LOT NUMBER: V1010. EVENTS REPORTED VIA: 2210968-2022-05314 AND THIS REPORT.
PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 8/30/2022 H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND H3 INVESTIGATIONAL SUMMARY: COMPLAINT SAMPLE: 01 OPENED UNIT OF COMPLAINT SAMPLE RECEIVED FOR INVESTIGATION; THE COMPLAINT SAMPLE CONSIST OF ONE OPEN SBF FOLDER, SUTURE, AND NEEDLE FOR CODE NW5050 LOT V1010. AS THE COMPLAINT SAMPLE RECEIVED IN OPEN CONDITION FURTHER INVESTIGATION WAS NOT PERFORMED ON COMPLAINT SAMPLE EXCEPT VISUAL INSPECTION. RECEIVED SUTURE WAS VISUALLY INSPECTED AND CHECKED AGAINST MENTIONED VOC PERFORMANCE-PULL OFF SUTURE NEEDLE BUT SAME WAS NOT EVIDENT AT THE OPEN ENDS OF SUTURE AS WELL AS IN NEEDLE. THE SURFACE OF SUTURE WAS FOUND TO BE ROUGH WHICH INDICATED THAT THE SUTURE WAS HANDLED WITH FORCE OR KEPT ABOVE TEMPERATURE EXCEEDING CONDITION. RETURNED NEEDLE WAS VISUALLY INSPECTED AND FOUND SATISFACTORY. BATCH RECORD REVIEW: AS A PART OF FURTHER INVESTIGATION BATCH MANUFACTURING RECORD WAS REVIEWED FOR CODE NW5050 LOT V1010.THE BATCH MANUFACTURING RECORD WAS REVIEWED FOR ANY PROCESS DEVIATION, BUT NO DEVIATION WAS OBSERVED. FINISHED GOOD RECORD WAS REVIEWED FOR TENSILE STRENGTH VALUE AND NEEDLE PULL-OFF VALUE AT RELEASE AND FOUND TO MEET THE SPECIFICATION. FROM THE BATCH RECORD REVIEW, IT HAS BEEN OBSERVED THAT THERE WAS NO ISSUE RELATED TO THE SUTURE QUALITY AND PROCESSING OF THIS INCIDENT LOT. RETAIN SAMPLE: FIVE RETAIN SAMPLES OF INCIDENT CODE NW5050 LOT V1010 WERE RETRIEVED FOR ANALYSIS. THE PRIMARY PACKS OF RETAIN SAMPLES WERE VISUALLY INSPECTED FOR ATTRIBUTE DEFECTS LIKE PSEUDO SEAL, PIN HOLE, PRODUCT IN SEAL, PRESS MARKS ON PACK BUT NO SUCH DEFECTS WERE OBSERVED. THE PRIMARY PACKS WERE OPENED, AND SUTURES AND NEEDLES WERE FOUND INTACT. THE SUTURES WERE PHYSICALLY INSPECTED FOR ANY ATTRIBUTE DEFECTS LIKE KINKS, WEAK SPOTS, BROKEN PIECE, FRAY, BRITTLENESS, DETACHED NEEDLES BUT NO SUCH DEFECTS WERE OBSERVED. THE NEEDLES WERE INSPECTED FOR ANY ATTRIBUTE DEFECTS LIKE BEND, CRACKED BARREL, FINS BUT NO SUCH DEFECTS WERE OBSERVED. THE RETAIN SAMPLES WERE TESTED FOR NEEDLE PULL TEST AND FOUND TO MEET THE SPECIFICATION. AS THE COMPLAINT IS RELATED TO PERFORMANCE-PULL OFF SUTURE NEEDLE, NEEDLE PULL TEST IS APPLICABLE & MEASURABLE PARAMETER. NEEDLE PULL-OFF TEST WAS PERFORMED OVER FIVE RETAIN SAMPLES TO CHECK THE BEHAVIOR OF THE SWAGING PROCESS. THE AVERAGE NEEDLE PULL VALUE OF THE RETAIN SAMPLE WAS FOUND TO BE 10.49 N AND VALUE AT RELEASE WAS FOUND TO BE 11.23 N WHICH MEETS THE AVERAGE USP SPECIFICATION REQUIREMENT I.E. NLT 4.41 N. ALL THE INDIVIDUAL AS WELL AS AVERAGE NEEDLE PULL-OFF VALUES WERE FOUND TO MEET THE USP SPECIFICATION REQUIREMENTS. THIS ANALYSIS SHOWS THAT THERE WAS NO ISSUE RELATED TO PROCESSING OF THE LOT. ALL THE VALUES ARE WITHIN THE CONTROL LIMITS. THE REPORTED INCIDENT WAS ONE AND ISOLATED CASE FOR CODE NW5050 LOT V1010. NO OTHER EVENT WAS REPORTED FOR SAME DESCRIPTION FROM OTHER PARTS OF COUNTRY. HENCE, THE COMPLAINT COULD NOT BE CONFIRMED. CONSIDERING ABOVE INVESTIGATION ADEQUATE TO ADDRESS THE REPORTED COMPLAINT, THIS COMPLAINT IS RECOMMENDED FOR CLOSURE APPROVAL. 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. EVENTS REPORTED VIA: 2210968-2022-05314. PRODUCT COMPLAINT #(B)(4). DATE SENT TO THE FDA: 8/30/2022 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: 8/3/2022. 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. H3 INVESTIGATIONAL SUMMARY: COMPLAINT SAMPLE: COMPLAINT SAMPLE NOT RECEIVED FOR INVESTIGATION. BATCH RECORD REVIEW: AS A PART OF FURTHER INVESTIGATION BATCH MANUFACTURING RECORD WAS REVIEWED FOR CODE NW018 LOT V1010.THE BATCH MANUFACTURING RECORD WAS REVIEWED FOR ANY PROCESS DEVIATION, BUT NO DEVIATION WAS OBSERVED. FINISHED GOOD RECORD WAS REVIEWED FOR TENSILE STRENGTH VALUE AND NEEDLE PULL-OFF VALUE AT RELEASE AND FOUND TO MEET THE SPECIFICATION. FROM THE BATCH RECORD REVIEW, IT HAS BEEN OBSERVED THAT THERE WAS NO ISSUE RELATED TO THE SUTURE QUALITY AND PROCESSING OF THIS INCIDENT LOT. RETAIN SAMPLE: FIVE RETAIN SAMPLES OF INCIDENT CODE NW018 LOT V1010 WERE RETRIEVED FOR ANALYSIS. THE PRIMARY PACKS OF RETAIN SAMPLES WERE VISUALLY INSPECTED FOR ATTRIBUTE DEFECTS LIKE PSEUDO SEAL, PIN HOLE, PRODUCT IN SEAL, PRESS MARKS ON PACK BUT NO SUCH DEFECTS WERE OBSERVED. THE PRIMARY PACKS WERE OPENED, AND SUTURES AND NEEDLES WERE FOUND INTACT. THE SUTURES WERE PHYSICALLY INSPECTED FOR ANY ATTRIBUTE DEFECTS LIKE KINKS, WEAK SPOTS, BROKEN PIECE, FRAY, BRITTLENESS, DETACHED NEEDLES BUT NO SUCH DEFECTS WERE OBSERVED. THE NEEDLES WERE INSPECTED FOR ANY ATTRIBUTE DEFECTS LIKE BEND, CRACKED BARREL, FINS BUT NO SUCH DEFECTS WERE OBSERVED. THE RETAIN SAMPLES WERE TESTED FOR NEEDLE PULL TEST AND FOUND TO MEET THE SPECIFICATION. AS THE COMPLAINT IS RELATED TO PERFORMANCE-PULL OFF SUTURE NEEDLE, NEEDLE PULL TEST IS APPLICABLE & MEASURABLE PARAMETER. NEEDLE PULL-OFF TEST WAS PERFORMED OVER FIVE RETAIN SAMPLES TO CHECK THE BEHAVIOR OF THE SWAGING PROCESS. THE AVERAGE NEEDLE PULL VALUE OF THE RETAIN SAMPLE WAS FOUND TO BE 15.84 N AND VALUE AT RELEASE WAS FOUND TO BE 18.54 N WHICH MEETS THE AVERAGE USP SPECIFICATION REQUIREMENT I.E. NLT 6.67 N. ALL THE INDIVIDUAL AS WELL AS AVERAGE NEEDLE PULL-OFF VALUES WERE FOUND TO MEET THE USP SPECIFICATION REQUIREMENTS. THIS ANALYSIS SHOWS THAT THERE WAS NO ISSUE RELATED TO PROCESSING OF THE LOT. ALL THE VALUES ARE WITHIN THE CONTROL LIMITS. THE REPORTED INCIDENT WAS ONE AND ISOLATED CASE FOR CODE NW018 LOT V1010. NO OTHER EVENT WAS REPORTED FOR SAME DESCRIPTION FROM OTHER PARTS OF COUNTRY. HENCE, THE COMPLAINT COULD NOT BE CONFIRMED. CONSIDERING ABOVE INVESTIGATION ADEQUATE TO ADDRESS THE REPORTED COMPLAINT, THIS COMPLAINT IS RECOMMENDED FOR CLOSURE APPROVAL. 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 THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE THREAD GOT DETACHED FROM NEEDLE AT SWAGE POINT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2067556 | NON ABSORBABLE SURGICAL SUTURE | SUTURE, NONABSORBABLE, SILK | GAP | ETHICON INC. | V1010 | ||
| 914208 | NON ABSORBABLE SURGICAL SUTURE | SUTURE, NONABSORBABLE, SILK | GAP | ETHICON INC. | V1010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |