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 2017-03-21 for MONOMAX VIOLET 1(4)150CM HR48 LOOP(M) B0041119 manufactured by B.braun Surgical Sa.
[70520675]
(b)(4). Manufacturing site evaluation: samples received: 3 unopened pouches. Analysis and results: there are no previous complaints of this code batch. Manufactured and distributed (b)(4) units of this code batch. There are no units in stock. Received three closed samples. Tightness test to the samples received has been performed and the units are tight. Tested the knot pull tensile strength of the samples received and the results fulfill the oem requirements. Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill the requirements. Remarks: when working with monomax suture material, great care should be taken to avoid any crushing or crimping damage of the monofilament by instruments such as forceps or needle holders. Final conclusion: although the results of the samples received fulfill the oem specifications, note of this incident is taken in order to assess if new or additional actions are needed. Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions. Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.
Patient Sequence No: 1, Text Type: N, H10
[70520676]
Country of complaint: (b)(6). It is reported that the thread breaks during knotting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2017-00150 |
| MDR Report Key | 6422005 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-21 |
| Date of Report | 2017-03-21 |
| Date Facility Aware | 2017-03-13 |
| Date Mfgr Received | 2017-02-20 |
| Date Added to Maude | 2017-03-21 |
| 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)150CM HR48 LOOP(M) |
| Generic Name | SUTURES |
| Product Code | NWJ |
| Date Received | 2017-03-21 |
| Returned To Mfg | 2017-03-16 |
| Model Number | B0041119 |
| Catalog Number | B0041119 |
| Lot Number | 116203 |
| 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 | 2017-03-21 |