MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-23 for SILKAM BLACK 3/0 (2) 75CM DS19 C0765210 manufactured by B. Braun Surgical, S.a..
[184482710]
Analysis and results: there are no previous complaints of this code-batch. We manufactured and distributed in the market 6,480 units of this code-batch. There are no units in our stock. We have received 24 closed samples for analysis. We have tested the needle attachment strength of the samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 0. 80 kgf in average and 0. 53 kgf in minimum (ep requirements: 0. 69 kgf in average and 0. 35 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 requirements. Needle attachment strength results before releasing the product were 1. 07 kgf in average and 0. 84 kgf in minimum and fulfilled ep requirements. 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. We regret any inconvenience this issue may have caused and thank you for your collaboration. 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
[184482711]
It was reported that there was an issue with silkam suture. The client reported that the needle detached from the thread at knotting during open surgery. It happened 3 times, with different sutures of the same box.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2020-00167 |
| MDR Report Key | 9865478 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-08-01 |
| Date Added to Maude | 2020-03-23 |
| 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 SILVIA ORUS |
| 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 | SILKAM BLACK 3/0 (2) 75CM DS19 |
| Generic Name | OTHER SUTURE |
| Product Code | GAP |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2020-03-06 |
| Model Number | C0765210 |
| Catalog Number | C0765210 |
| Lot Number | 619314 |
| 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?, BARCELONA 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |