VCL+ VIO 36IN 1 S/A CTX
Report
- Report Number
- 2210968-2021-12439
- Event Type
- Malfunction
- Date Received
- December 8, 2021
- Date of Event
- November 12, 2021
- Report Date
- December 8, 2021
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- UDI-DI
- 10705031052857
- PMA / PMN Number
- K132580
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 01/25/2022. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. PART 4 SUBPART B. 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. H3 INVESTIGATION SUMMARY: VISUAL ANALYSIS OF THE RETURNED PRODUCT REVEALED THAT ONE NEEDLE/SUTURE PIECE PRODUCT CODE VCP371 WAS RECEIVED FOR EVALUATION. AS PER VISUAL INSPECTION, THE STRAND WAS OBSERVED BROKEN AND APPARENTLY DEGRADATION PROCESS CAUSED BY EXPOSURE TO ENVIRONMENT COULD BE OBSERVED. THE PRODUCT CODE VCP371 CONTAINS AN ABSORBABLE SUTURE. AS THE SAMPLE WAS RECEIVED OPEN, THE TIME OF EXPOSED TO THE ENVIRONMENT COULD NOT BE DETERMINED AND FUNCTIONAL TEST CANNOT BE PERFORMED. THE PACKAGING WAS NOT RECEIVED FOR EVALUATION TO DETERMINE THE CAUSE. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED THE REPORTED COMPLAINT. AS PART OF QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. VISUAL ANALYSIS OF THE RETURNED PRODUCT REVEALED THAT ONE OPENED SAMPLE PRODUCT CODE VCP371 WAS RECEIVED FOR EVALUATION. AS PER VISUAL INSPECTION THE SUTURE WAS OBSERVED WITH PROCESS OF DEGRADATION CAUSED BY EXPOSURE TO THE ENVIRONMENT. THE PRODUCT CODE VCP371 CONTAINS AN ABSORBABLE SUTURE. AS THE PACKAGE WAS RECEIVED OPEN, THE TIME OF EXPOSED TO THE ENVIRONMENT COULD NOT BE DETERMINED AND FUNCTIONAL TEST CANNOT BE PERFORMED. THE FOIL WAS VISUALLY INSPECTED, AND A HOLE IN CAVITY AND WRINKLES WERE OBSERVED. THIS CONDITION CONTRIBUTED TO DEGRADATION OF THE SUTURE. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH ¿ = 275 G/M.
(B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER QJMRDR AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. ATTEMPTS ARE BEING 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. INVESTIGATION SUMMARY: AFTER VISUAL INSPECTION OF TWO IMAGES RECEIVED FOR EVALUATION. A DETACHED NEEDLE COULD BE SEEN WITH A PIECE OF SUTURE STILL ATTACHED TO THE BORE OF THE CYLINDER AND SECTIONS OF SUTURE WITH PRODUCT CODE VCP371H. THE THREAD APPEARS TO BE DAMAGED OR FRAYED, CAUSING THE NEEDLE TO SEPARATE FROM THE SUTURE. AS PART OF OUR QUALITY PROCESS, MANUFACTURING RECORDS FOR THIS BATCH SERIAL NUMBER WERE REVIEWED AND MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED COMPLAINT, AS THE SAMPLE WAS NOT RETURNED FOR ANALYSIS. AS PART OF ETHICON'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH ¿ 275 G/M.
(B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER QJMRDR AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. ATTEMPTS ARE BEING 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. INVESTIGATION SUMMARY: AFTER VISUAL INSPECTION OF TWO IMAGES RECEIVED FOR EVALUATION. A DETACHED NEEDLE COULD BE SEEN WITH A PIECE OF SUTURE STILL ATTACHED TO THE BORE OF THE CYLINDER AND SECTIONS OF SUTURE WITH PRODUCT CODE VCP371H. THE THREAD APPEARS TO BE DAMAGED OR FRAYED, CAUSING THE NEEDLE TO SEPARATE FROM THE SUTURE. AS PART OF OUR QUALITY PROCESS, MANUFACTURING RECORDS FOR THIS BATCH SERIAL NUMBER WERE REVIEWED AND MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED COMPLAINT, AS THE SAMPLE WAS NOT RETURNED FOR ANALYSIS. AS PART OF ETHICON'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH ¿ 275 G/M.
IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1857890 | VCL+ VIO 36IN 1 S/A CTX | SUTURE, ABSORBABLE, SYNTHETIC | GAM | ETHICON INC. | VCP371H | QJMRDR | 10705031052857 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |