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 2017-03-03 for MONOMAX VIOLET 1(4)150CM HR48 LOOP(M) B0041119 manufactured by B.braun Surgical Sa.
[69097307]
(b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[69097308]
Country of complaint: (b)(6). It was reported that the threads are sticky and therefore it is difficult to remove the out of the primary package.
Patient Sequence No: 1, Text Type: D, B5
[73477918]
Samples received: 16 unopened and 1 opened pouches. Analysis and results: there are no previous complaints of this batch. We manufactured and distributed in the market 1,080 units of this batch. There are no units in stock. We have received 16 closed samples and one open sample (only the second pack is open). Tightness test to the closed samples received has been performed and the units are tight. Extraction of the suture in the received samples is correct and the current one. Suture has been pulled out without difficulty and does not become tangled. We have checked carefully all samples received and no defects or irregularities have been found. Thread surface on the samples received is correct and the usual one. Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil b. Braun surgical requirements. Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product. Corrective/preventive actions: according to 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
| Report Number | 3003639970-2017-00107 |
| MDR Report Key | 6378641 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-03 |
| Date of Report | 2017-03-27 |
| Date Facility Aware | 2017-02-23 |
| Date Mfgr Received | 2017-02-03 |
| Date Added to Maude | 2017-03-03 |
| 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 | 2017-03-03 |
| Returned To Mfg | 2017-02-23 |
| Model Number | B0041119 |
| Catalog Number | B0041119 |
| Lot Number | 116373 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-03-03 |