MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2015-07-15 for MONOMAX VIOLET 2/0 (3) 150CM HR30 (M) B0041453 manufactured by B. Braun Surgical S.a..
[6431964]
Country of complaint: (b)(6). The inner foil and outer foil are welded together, the inner package is no longer sterile when released into the sterile field.
Patient Sequence No: 1, Text Type: D, B5
[13509456]
Samples received: 2 open pouches. There are no previous complaints of this code batch. There are no units in stock. We have received two open samples, only the second pack is opened. Both open samples received do not have the aluminum pouch stuck to the outer paper foil. We need defective samples showing the defect to properly assess the complaint. Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill oem requirements. Corrective/preventive actions: not applicable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00593 |
| MDR Report Key | 4926080 |
| Report Source | 01,07,08 |
| Date Received | 2015-07-15 |
| Date of Report | 2015-07-15 |
| Date of Event | 2015-06-15 |
| Date Mfgr Received | 2015-06-15 |
| Date Added to Maude | 2015-07-23 |
| 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) 08191 |
| Manufacturer Country | ES |
| Manufacturer Postal Code | 08191 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONOMAX VIOLET 2/0 (3) 150CM HR30 (M) |
| Generic Name | SUTURE |
| Product Code | NWJ |
| Date Received | 2015-07-15 |
| Model Number | B0041453 |
| Catalog Number | B0041453 |
| Lot Number | 113463 |
| 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) 08191 ES 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-15 |