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 2020-03-18 for MONOMAX VIOLET 2/0 (3) 150CM HR26 B0041444 manufactured by B. Braun Surgical, S.a..
[183935382]
Analysis and results: there are no previous complaints of this code-batch. We have received two cases regarding the same issue from the same customer (this report is for the first case). We manufactured and distributed in the market (b)(4) units of this code-batch. There are no units in our stock. We have received 5 closed samples for analysis to analyze both cases. Tightness test to the samples received has been performed and the units are tight. We have tested the knot pull tensile strength of the samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 3. 81 kgf in average and 3. 46 kgf in minimum (ep requirements: 2. 73 kgf in average and 1. 37 kgf in minimum). Reviewed the batch manufacturing record of this product, there are no incidences related to this issue and the results during the process fulfil usp/ep and b. Braun surgical requirements. Remarks: when working with monomax suture materials great care should be taken to ensure that the use of surgical instruments, such as tweezers and needle holders do not damage the material by being pinched or kinked. Final conclusion: although the results of the samples received fulfil the specifications of european pharmacopoeia/ b. Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed. 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 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
[183935383]
It was reported that there was an issue with monomax suture. The client reported that the thread breaks very easily when knotting. It occurred during abdominal closure in two different surgeries and two different surgeons. No delay in surgery and patient outcome as good (this report is for the first patient). Additional information has not been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2020-00168 |
| MDR Report Key | 9848047 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2018-10-29 |
| Date Added to Maude | 2020-03-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS S OR |
| Manufacturer Street | CARRETERA DE TERRASSA, 121 |
| Manufacturer City | RUB 08191 |
| Manufacturer Country | SP |
| Manufacturer Postal | 08191 |
| Manufacturer G1 | B. BRAUN SURGICAL, S.A. |
| Manufacturer Street | CARRETERA DE TERRASSA, 121 |
| Manufacturer City | RUB 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 |
| Generic Name | SYNTHETIC ABSORBABLE MONOFILAR SUTURE |
| Product Code | NWJ |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2020-03-10 |
| Model Number | B0041444 |
| Catalog Number | B0041444 |
| Lot Number | 118441 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN SURGICAL, S.A. |
| Manufacturer Address | CARRETERA DE TERRASSA, 121 RUB?, 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |