MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for PROLENE SUT 30IN(75CM) 6-0 BLU 8709H manufactured by Ethicon Inc..
[188523648]
(b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. Additional information was requested and the following was obtained: event date - unknown. Account didn't specify. Please provide specific quantity of devices with product code and lot number involved in this single procedure. Unknown - sending three boxes. Evaluation: unopened samples of product were received. During the visual inspection of unopened samples, no defects were found on the packages. The samples were opened, and the swage and attachment area were noted to be as expected. The sutures were dispensed without problems and examined along of the strand with no defects, damage or suture breakage were noted. A functional test was performed and the tensile strength force was above the minimum requirement. The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch. Per the condition of the samples received, no suture breakage was found and the tested samples met the finished goods requirements.
Patient Sequence No: 1, Text Type: N, H10
[188523649]
It was reported that a patient underwent cabg procedure on (b)(6) 2020 and the suture was used. During surgery, the surgeon went to tie the anastomosis when the sutures broke. New sutures were used to complete the case with no patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02479 |
| MDR Report Key | 9908106 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-10-18 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON INC.-SAN LORENZO PR |
| Manufacturer Street | 982 ROAD 183 KM 8.3 |
| Manufacturer City | SAN LORENZO 00754 |
| Manufacturer Country | * |
| Manufacturer Postal Code | 00754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROLENE SUT 30IN(75CM) 6-0 BLU |
| Generic Name | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE |
| Product Code | GAW |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-19 |
| Model Number | 8709H |
| Catalog Number | 8709H |
| Lot Number | PLH703 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |