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 2016-08-01 for MONOMAX VIOLET 1(4)150CM HR48 LOOP(M) B0041119 manufactured by B.braun Surgical Sa.
[50919964]
Evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[50920025]
Country of complaint: (b)(4). The customer reported inappropriate quality of product was found when blisters were opened.
Patient Sequence No: 1, Text Type: D, B5
[57731668]
Samples received: 41 unopened and 5 open pouches. Analysis and results: there are no previous complaints of this code batch. Approx (b)(4) units of this product were manufactured and distributed in the market, there are no units in stock. Received 41 closed and 5 open units (unused). Three of the open units have the thread damaged in some parts. The damaged units have been submitted to high temperatures and thread has melted. The aluminum pouch of the units have been checked and no defects have been found. The 41 closed samples received have been opened and all threads are correct, no thermal damage have been found in the thread surface. Therefore, as no other complaints have been received for this code-batch, this is considered an accidental and isolated problem. Root cause analysis is still on going, origin of the defect has not been achieved. Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfilled the oem requirements. Final conclusion: complaint is justified. The results of the samples received does not fulfill the oem requirements. Corrective/preventive actions: according to the internal procedures, there is no need to establish corrective or 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
| Report Number | 2916714-2016-00624 |
| MDR Report Key | 5837402 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-08-01 |
| Date of Report | 2016-10-10 |
| Date of Event | 2016-07-07 |
| Date Facility Aware | 2016-07-21 |
| Date Mfgr Received | 2016-09-01 |
| Date Added to Maude | 2016-08-01 |
| 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 | 0 |
| 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)150CM HR48 LOOP(M) |
| Generic Name | SUTURES |
| Product Code | NWJ |
| Date Received | 2016-08-01 |
| Model Number | B0041119 |
| Catalog Number | B0041119 |
| Lot Number | 116092 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-08-01 |