MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-19 for ETHILON BLK 13CM 9-0 BV100-4 2829G W2829 manufactured by Ethicon Inc..
[184662639]
(b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. 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. The following information was requested, but unavailable: please clarify the reported device issue 'the suture strand was not properly connected to the needle' was the needle separating form the suture thread? Or suture fraying? Or other, explain? What was done to manage the 'tearing the vessel wall'? Did the patient have surgical time prolonged, change in procedure or post-op care due to this issue? How was case completed? Device return status.
Patient Sequence No: 1, Text Type: N, H10
[184662640]
It was reported that a patient underwent an unknown procedure on a unknown date and the suture was used. It was reported that the suture was tearing the vessel wall and when inspected under a microscope it turned out that the suture strand was not properly connected to the needle. A like device from another batch was used to complete the procedure. There were no adverse patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02240 |
| MDR Report Key | 9857280 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-07-16 |
| Date Added to Maude | 2020-03-19 |
| 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 | ETHILON BLK 13CM 9-0 BV100-4 |
| Generic Name | SUTURE, NONABSORBABLE, SYNTHETIC |
| Product Code | GAR |
| Date Received | 2020-03-19 |
| Model Number | 2829G |
| Catalog Number | W2829 |
| Lot Number | PHR771 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-19 |