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 2015-12-30 for MONOMAX VIOLET 2/0 (3) 150CM HR26 (M) B0041444 manufactured by B.braun Surgical Sa.
[34762895]
Reported device not marketed in the u. S. , however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device registered within the u. S. (b)(4). Manufacturing site evaluation: samples received: 11 unopened pouches and 1 open unit (only 2nd pack open). Analysis and results: there are no previous complaints of this code batch. There were 1,320 units manufactured and distributed of this code batch, there are no units in stock. All closed samples received are tight. Seven of the 11 pouches received have the 1st pack sealed to the 2nd pack, in the 4th sealing, when the packs were opened. This defect is due to an accidental effect of the welding machine, these units were not sorted out by the personnel involved in this process. Taking into account that the results of samples received do not fulfill the oem requirements. Final conclusion: complaint is justified. Actions on product: based on the conclusion derived from investigation, it is required replace this code/batch to the customer or a refund. Corrective/preventive actions: according to the internal procedures, corrective or preventive actions has been implemented through oem.
Patient Sequence No: 1, Text Type: N, H10
[34762896]
Country of complaint: (b)(6). Inner foil is welded with outer foil. Eleven unopened pouches and 1 opened (only the 2nd pack is opened).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2015-01155 |
| MDR Report Key | 5336540 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-12-30 |
| Date of Report | 2015-12-29 |
| Date of Event | 2015-12-02 |
| Date Facility Aware | 2015-12-21 |
| Date Mfgr Received | 2015-12-14 |
| Device Manufacturer Date | 2014-11-21 |
| Date Added to Maude | 2015-12-30 |
| 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 2/0 (3) 150CM HR26 (M) |
| Generic Name | SUTURES |
| Product Code | NWJ |
| Date Received | 2015-12-30 |
| Returned To Mfg | 2015-12-23 |
| Model Number | B0041444 |
| Catalog Number | B0041444 |
| Lot Number | 114475V004 |
| Device Expiration Date | 2019-11-01 |
| 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 | 2015-12-30 |