VCL+ UD 8X18IN 0 S/A CTB-1 CR
Report
- Report Number
- 2210968-2021-12808
- Event Type
- Malfunction
- Date Received
- December 21, 2021
- Date of Event
- November 25, 2021
- Report Date
- February 1, 2022
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- UDI-DI
- 10705031056626
- PMA / PMN Number
- K032420
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT COMPLAINT # ==>(B)(4) CORRECTED INFORMATION: H3 TRADE NAME - IRGACARE® ACTIVE INGREDIENT(S) ¿ TRICLOSAN DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL STRENGTH ¿ = 275 ¿G/M 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.
(B)(4). ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: SUTURE METHOD: INTERRUPTED SUTURING. PLEASE PROVIDE LOT NUMBER: RJMKBB. PLEASE CONFIRM HOW MANY SUTURES SEPARATED FROM THE NEEDLE DURING SUTURING ON THIS ONE PATIENT DURING THIS SINGLE SURGICAL PROCEDURE? QTY OF PRODUCT INVOLVED IS 5. HOW WAS PROCEDURE SUCCESSFULLY COMPLETED? NO FURTHER INFORMATION IS AVAILABLE. PLEASE PROVIDE THE RETURN STATUS OF THE DEVICE(S) AS IT HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE HAS BEEN SHIPPED, PLEASE PROVIDE THE SHIPMENT TRACKING DETAILS. WE REGULARLY CONTACT WITH SALES REP ABOUT THE DEVICE RETURNING. NO FURTHER INFORMATION WILL BE PROVIDED. 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 THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. TRADE NAME - IRGACARE, ACTIVE INGREDIENT(S)- TRICLOSAN, DOSAGE FORM - SUTURE/SOLID/PARENTERAL, STRENGTH -= 275 G /M. RELATED TO: 2210968-2021-12807, 2210968-2021-12809, 2210968-2021-12810, 2210968-2021-12811.
PRODUCT COMPLAINT # ==> (B)(4)ADDITIONAL INFORMATION: D9, H4, H6 H6 COMPONENT CODE: G07002 REPORTED CONDITION NOT CONFIRMED INVESTIGATION SUMMARY ==> THREE PACKETS OF PRODUCT CODE VCPB840D WERE RETURNED FOR ANALYSIS WITH THE PACKAGING CLOSED. UPON INITIAL INSPECTION, OF THE SAMPLES, NO EXTERNAL DAMAGES WERE OBSERVED ON THE PACKETS. IN ORDER TO EVALUATE THE CONDITIONS OF THE RETURNED SAMPLES, THE PACKETS WERE OPENED, AND NO DEFECTS WERE DETECTED. THE SWAGE AND ATTACHMENT AREA WAS 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, AND THE PULL FORCE MEETS THE REQUIREMENTS. 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 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. TRADE NAME - IRGACARE® ACTIVE INGREDIENT(S) ¿ TRICLOSAN DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL STRENGTH ¿ = 275 ¿G/M 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. CORRECTED INFORMATION: D9, H3
PRODUCT COMPLAINT NUMBER: (B)(4). ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: SUTURE METHOD: INTERRUPTED SUTURING. PLEASE PROVIDE LOT NUMBER: RJMKBB. PLEASE CONFIRM HOW MANY SUTURES SEPARATED FROM THE NEEDLE DURING SUTURING ON THIS ONE PATIENT DURING THIS SINGLE SURGICAL PROCEDURE? QTY OF PRODUCT INVOLVED IS 5. HOW WAS PROCEDURE SUCCESSFULLY COMPLETED? NO FURTHER INFORMATION IS AVAILABLE. PLEASE PROVIDE THE RETURN STATUS OF THE DEVICE(S) AS IT HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE HAS BEEN SHIPPED, PLEASE PROVIDE THE SHIPMENT TRACKING DETAILS. WE REGULARLY CONTACT WITH SALES REP ABOUT THE DEVICE RETURNING. NO FURTHER INFORMATION WILL BE PROVIDED. 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 THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. TRADE NAME - IRGACARE, ACTIVE INGREDIENT(S)- TRICLOSAN, DOSAGE FORM - SUTURE/SOLID/PARENTERAL, STRENGTH -= 275 G /M. RELATED TO: 2210968-2021-12807, 2210968-2021-12809, 2210968-2021-12810, 2210968-2021-12811.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB/GYN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE THE PULL-OFF ISSUE OCCURRED FREQUENTLY DURING INTERRUPTED SUTURING. THEY WERE CONTROL RELEASE NEEDLES. FIVE DEVICES WERE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB/GYN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE THE PULL-OFF ISSUE OCCURRED FREQUENTLY DURING INTERRUPTED SUTURING. THEY WERE CONTROL RELEASE NEEDLES. FIVE DEVICES WERE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1951015 | VCL+ UD 8X18IN 0 S/A CTB-1 CR | SUTURE, ABSORBABLE, SYNTHETIC | GAM | ETHICON INC. | VCPB840D | RJMKBB | 10705031056626 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |