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 2020-03-31 for SAFIL VIOLET 0 (3.5) 90CM HR37S (M) C1048956 manufactured by B. Braun Surgical, S.a..
[186094835]
Analysis and results: there are no previous complaints of this code-batch. We manufactured (b)(4) units of this code-batch. There are (b)(4) units in our stock. We have not received any sample from the customer. We have requested one box (36 closed samples) from stock for analysis. Tightness test to the samples of our stock has been performed and the units are tight. We have tested the knot pull tensile strength of the samples received from stock and the results fulfil the requirements of the european pharmacopoeia (ep): 5. 34 kgf in average and 4. 89 kgf in minimum (ep requirements: 3. 98 kgf in average and 1. 89 kgf in minimum). Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b. Braun surgical requirement final conclusion: although the results of the samples received from stock 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
[186094836]
It was reported that there was an issue with safil violet suture. On (b)(6) 2019, at 9 a. M. , the patient was threatened with labor due to scarred uterus and underwent lower uterine segment caesarean section. Absorbable surgical needle suture (safil violet) was used to suture the wound. During the suture process, the middle segment of the suture suddenly broke, and the doctor stopped using it immediately after discovering it. The nurse immediately took a new pack of absorbable surgical needle sutures. The wound suture was successfully completed. .
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2020-00174 |
| MDR Report Key | 9907860 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-06-12 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2017-12-03 |
| Date Added to Maude | 2020-03-31 |
| 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 | SAFIL VIOLET 0 (3.5) 90CM HR37S (M) |
| Generic Name | SYNTHETIC ABSORBABLE BRAIDED SUTURE |
| Product Code | GAM |
| Date Received | 2020-03-31 |
| Model Number | C1048956 |
| Catalog Number | C1048956 |
| Lot Number | 117487 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-31 |