MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2015-02-27 for MONOMAX VIOLET 0 (3,5) 150CM HR26 (M) B0041441 manufactured by B Braun Surgical S.a..
[5601066]
Country of complaint: (b)(6). Inner foil was welded with outer foil. Due to this fact a sterile withdrawal was not possible.
Patient Sequence No: 1, Text Type: D, B5
[13043877]
Us reporting agent notified on: (b)(6)2015. Manufacturing site evaluation: samples received: 26 unopened pouches and 1 opened. There are no previous complaints of this code batch. There are no units in oem stock. Received 26 closed samples and one opened (only the second pack is opened and with the aluminum pack stuck to the paper foil). This defect is caused in the welding machine during the manufacturing process of the product. Final conclusion: the complaint is corresponding (justified). Corrective/preventive actions: not applicable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00149 |
| MDR Report Key | 4645900 |
| Report Source | 01,07 |
| Date Received | 2015-02-27 |
| Date of Report | 2015-02-27 |
| Date Mfgr Received | 2015-01-12 |
| Device Manufacturer Date | 2014-11-01 |
| Date Added to Maude | 2015-05-11 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | B BRAUN SURGICAL SA |
| Manufacturer Street | 121 CARRETERA DE TERRASSA |
| Manufacturer City | RUBI BARCELONA |
| Manufacturer Country | SP |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONOMAX VIOLET 0 (3,5) 150CM HR26 (M) |
| Generic Name | SYNTHETIC ABSORBABLE SUTURE |
| Product Code | NWJ |
| Date Received | 2015-02-27 |
| Model Number | B0041441 |
| Catalog Number | B0041441 |
| Lot Number | 11/01/2019 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B BRAUN SURGICAL S.A. |
| Manufacturer Address | RUBI (BARCELONA) SP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-27 |