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 2017-06-09 for MONOMAX VIOLET 1(4)150CM HR48 LOOP(M) B0041119 manufactured by B.braun Surgical Sa.
[77457584]
(b)(4). Manufacturing site evaluation: samples received: 1 open pouch. Analysis and results: there is one previous complaint of the same code-batch but regarding other issue. Manufactured and distributed in the market (b)(4) units of this code batch. There are no units in stock. The sample received has the first pack sealed to second pack in the 4th sealing, as can be seen in 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: taking into account that the sample received does not fulfill the oem specifications, it is concluded that the complaint is justified. Corrective/preventive actions: this complaint will be included in the analysis of trending, and corrective action will be open if applies.
Patient Sequence No: 1, Text Type: N, H10
[77457585]
County of complaint: (b)(6). It is reported the monomax packaging is welded to the secondary packaging. When trying to remove the monomax packaging from the secondary packaging, it will risk sterilization..
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2017-00294 |
| MDR Report Key | 6632054 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-06-09 |
| Date of Report | 2017-06-09 |
| Date of Event | 2017-05-17 |
| Date Facility Aware | 2017-05-26 |
| Date Mfgr Received | 2017-05-17 |
| Date Added to Maude | 2017-06-09 |
| 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 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | B.BRAUN SURGICAL SA |
| Manufacturer Street | 121 CARRETERA DE TERRASSA |
| Manufacturer City | RUBI, 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)150CM HR48 LOOP(M) |
| Generic Name | SUTURES |
| Product Code | NWJ |
| Date Received | 2017-06-09 |
| Returned To Mfg | 2017-05-23 |
| Model Number | B0041119 |
| Catalog Number | B0041119 |
| Lot Number | 116373V003 |
| 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, 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-09 |