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 2020-03-31 for NOVOSYN VIOLET 0 (3.5) 90CM HR37S (M) C0068956 manufactured by B. Braun Surgical, S.a..
[186094464]
If additional information becomes available a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[186094465]
It was reported that there was an issue with novosyn violet suture. The client reported that during handling there is a separation of the needle from the thread (needle detachment). Sutures were used for laparoscopic surgery and the procedure was prolonged due to this issue. No patient information is available due to privacy protection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2020-00176 |
| MDR Report Key | 9907934 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-30 |
| Date Mfgr Received | 2020-03-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS SILVIA ORUS |
| Manufacturer Street | CARRETERA DE TERRASSA 121 |
| Manufacturer City | RUB 08191 |
| Manufacturer Country | SP |
| Manufacturer Postal | 08191 |
| Manufacturer G1 | B. BRAUN SURGICAL, S.A. |
| Manufacturer Street | CARRETERA DE TERRASSA 121 |
| Manufacturer City | RUB 08191 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 08191 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVOSYN VIOLET 0 (3.5) 90CM HR37S (M) |
| Generic Name | SYNTHETIC ABSORBABLE BRAIDED S |
| Product Code | GAM |
| Date Received | 2020-03-31 |
| Model Number | C0068956 |
| Catalog Number | C0068956 |
| Lot Number | 119376 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN SURGICAL, S.A. |
| Manufacturer Address | CARRETERA DE TERRASSA 121 RUB?, BARCELONA 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |