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 MONOPLUS VIOLET 4/0 (1.5) 45CM DS19 (M) C0024909 manufactured by B. Braun Surgical, S.a..
[184417384]
If additional information becomes avaiable a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[184417385]
It was reported that when opening the package, the surgeon noticed that the needle was detached. The product could not be used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2020-00163 |
| MDR Report Key | 9855750 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-03-02 |
| 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 |
| 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 | MONOPLUS VIOLET 4/0 (1.5) 45CM DS19 (M) |
| Generic Name | SYNTHETIC ABSORBABLE MONOFILAR |
| Product Code | NEW |
| Date Received | 2020-03-19 |
| Model Number | C0024909 |
| Catalog Number | C0024909 |
| Lot Number | 119294 |
| 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 | 2020-03-19 |