VCL+ VIO 27IN 1 S/A CT
Report
- Report Number
- 2210968-2022-07199
- Event Type
- Malfunction
- Date Received
- September 1, 2022
- Report Date
- November 21, 2022
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- UDI-DI
- 10705031052659
- PMA / PMN Number
- K132580
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT COMPLAINT #: (B)(4). 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, 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. 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. PLEASE PROVIDE THE LOT NUMBER. DEVICE RETURN STATUS. WAS ANOTHER SUTURE USED TO SUCCESSFULLY COMPLETE THE SURGERY? TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH ¿ = 275 ¿G/M. EVENTS REPORTED VIA 2210968-2022-071200, 2210968-2022-071201, 2210968-2022-071202, 2210968-2022-071203, 2210968-2022-071204, 2210968-2022-071205, 2210968-2022-071206, 2210968-2022-071207, 2210968-2022-071208, 2210968-2022-071209, 2210968-2022-071210, AND 2210968-2022-071211.
PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 10/14/2022. 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, 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. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: COMPLAINT DETAILS : THE SUTURE BROKE. THE NEEDLE DETACHED FROM THE SUTURE. VCP353H. ALSO, THE LOT NUMBER IS PA2902. THE SUTURE BROKE. CORRECT DESCRIPTION : THE SUTURE BROKE FROM THE ROOT OF THE NEEDLE. THE SUTURE BROKE. THE NEEDLE DETACHED FROM THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: THIS FILE IS FOR VCP357H, WERE BOTH PRODUCT CODE VCP357H AND VCP353H INVOLVED IN THIS COMPLAINT? VCP357H WAS A WRONG NUMBER. CORRECT NUMBER IS VCP353H. ONLY VCP353H WAS INVOLVED IN THIS COMPLAINT. NO FURTHER INFORMATION WILL BE PROVIDED. EVENTS REPORTED VIA 2210968-2022-07199, 2210968-2022-071200, 2210968-2022-071201, 2210968-2022-071202, 2210968-2022-071203, 2210968-2022-071204, 2210968-2022-071205, 2210968-2022-071206, 2210968-2022-071207, 2210968-2022-071208, & 2210968-2022-071209. PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 10/14/2022. 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, 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: 09/22/2022 . H6 COMPONENT CODE: G07002 - 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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PRODUCT CODE : VCP357H: VCP353H. LOT NUMBER : UNK:PA2902.
PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 9/20/2022. 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, 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. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: QTY OF PRODUCT INVOLVED : (B)(4) QTY TO BE RETURNED : (B)(4) TRADE NAME - IRGACARE® ACTIVE INGREDIENT(S) ¿ TRICLOSAN DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL STRENGTH ¿ 275 G/M EVENTS REPORTED VIA 2210968-2022-07199, 2210968-2022-071200, 2210968-2022-071201, 2210968-2022-071202, 2210968-2022-071203, 2210968-2022-071204, 2210968-2022-071205, 2210968-2022-071206, 2210968-2022-071207, 2210968-2022-071208, & 2210968-2022-071209.
PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 09/09/2022. H6 COMPONENT CODE: G07002 - 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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: " PLEASE PROVIDE THE LOT NUMBER: NO FURTHER INFORMATION IS AVAILABLE. DEVICE RETURN STATUS: WE REGULARLY CONTACT WITH SALES REP ABOUT THE DEVICE RETURNING. NO FURTHER INFORMATION WILL BE PROVIDED."
PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 11/21/2022. 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, 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION EVALUATION WAS CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT ONE OPENED SAMPLE THAT PERTAINS TO PRODUCT CODE VCP353H WAS RETURNED TO ETHICON FOR ANALYSIS. DURING THE VISUAL INSPECTION OF THE DETACHED NEEDLE, LIGHT SWAGE WAS OBSERVED ON THE SWAGE AREA. THE BARREL HOLE WAS EXAMINED UNDER 20X MAGNIFICATION FOR SUTURE REMNANT, AND NONE WAS OBSERVED. THE SUTURE END WAS EXAMINED AND THERE ISN¿T SUFFICIENT IMPRESSION AT THE SWAGED END, RESULTING IN A LIGHT SWAGE. BASED ON THE INFORMATION CURRENTLY AVAILABLE, LIGHT SWAGE ISSUE WAS IDENTIFIED AS PULL OUT DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH QUALITY SYSTEM. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. EVENTS REPORTED VIA 2210968-2022-07199, 2210968-2022-071200, 2210968-2022-071201, 2210968-2022-071202, 2210968-2022-071203, 2210968-2022-071204, 2210968-2022-071205, 2210968-2022-071206, 2210968-2022-071207, 2210968-2022-071208, & 2210968-2022-071209.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE DURING USE. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2815071 | VCL+ VIO 27IN 1 S/A CT | SUTURE, ABSORBABLE, SYNTHETIC | GAM | ETHICON INC. | VCP357H | PA2902 | 10705031052659 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |