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 2016-04-07 for MONOMAX VIOLET 1(4)200CM HRT48 LOOP(M B0041231 manufactured by B.braun Surgical Sa.
[42160386]
(b)(4). Manufacturing site evaluation: samples received: 1 open pouch (only the second pack is opened). Analysis and results: there are no previous complaints of this code batch. There are no units in our stock. Received one open samples, with only the second pack opened. The first pack is closed. The sample received has the first pack sealed to second pack in the 4th sealing as can be seen in the enclosed picture. This defect took place in the welding machine and this unit was not sorted out by the personnel involved in this process. Final conclusion: complaint is justified. Taking into account that the sample received does not fulfill the oem requirements. Actions on product: based on the conclusion derived from investigation, it is required to replace this code/batch to the customer or offer a refund. Corrective/preventive actions: this complaint is recorded for trending analysis to assess if actions are needed in the future.
Patient Sequence No: 1, Text Type: N, H10
[42160387]
Country of complaint: (b)(6). Inner foil is welded with outer foil. Opening and steril withdrawal is not possible. Inner package is too big.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2016-00220 |
| MDR Report Key | 5555164 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-04-07 |
| Date of Report | 2016-04-07 |
| Date of Event | 2016-03-07 |
| Date Facility Aware | 2016-03-17 |
| Date Mfgr Received | 2016-03-10 |
| Device Manufacturer Date | 2015-10-01 |
| Date Added to Maude | 2016-04-07 |
| 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 | MS. 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 | SP |
| Manufacturer Postal Code | 08191 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONOMAX VIOLET 1(4)200CM HRT48 LOOP(M |
| Generic Name | SUTURES |
| Product Code | NWJ |
| Date Received | 2016-04-07 |
| Returned To Mfg | 2016-03-16 |
| Model Number | B0041231 |
| Catalog Number | B0041231 |
| Lot Number | 115404V004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B.BRAUN SURGICAL SA |
| Manufacturer Address | 121 CARRETERA DE TERRASSA RUBI, BARCELONA 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-07 |