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 2020-02-27 for SILKAM BLACK 3/0 (2) 75CM HR26 C0760412 manufactured by B.braun Surgical Sa.
[181217554]
Pma/510k: reported device not marketed in the u. S. , however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u. S. K990089. Investigation: samples received: 112 unopened pouches. Analysis and results: there is one previous complaint of the same code-batch. We manufactured 6,156 units of this code-batch. There are 180 units blocked in stock. We have received 112 closed samples for analysis. We have tested the knot pull tensile strength of all samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 1. 16 kgf in average and 0. 98 kgf in minimum (ep requirements: 0. 92 kgf in average and 0. 31 kgf in minimum). Nevertheless, we have also tested the needle attachment strength of the samples received and the results do not fulfil the requirements of the european pharmacopoeia. Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfilled usp/ep and b. Braun surgical requirements. Final conclusion: taking into account that the results of samples received do not fulfil the specifications of the european pharmacopoeia/b. Braun surgical specifications concerning needle attachment strength, we conclude that the complaint is confirmed. 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. No corrective/preventive actions needed.
Patient Sequence No: 1, Text Type: N, H10
[181217555]
It was reported that there is an issue with needle detachment. The reporter indicated that during a surgical procedure the needle detached from the thread breaking very easily. Patient information is not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2020-00108 |
| MDR Report Key | 9764656 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-01-31 |
| Date Added to Maude | 2020-02-27 |
| 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 | RUBI, BARCELONA 08191 |
| Manufacturer Country | SP |
| Manufacturer Postal | 08191 |
| Manufacturer G1 | B/ BRAUN SURGICAL SA |
| Manufacturer Street | 121 CARRETERA DE TERRASSA |
| Manufacturer City | RUBI, 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 HR26 |
| Generic Name | OTHER SUTURE |
| Product Code | GAP |
| Date Received | 2020-02-27 |
| Returned To Mfg | 2020-02-05 |
| Model Number | C0760412 |
| Catalog Number | C0760412 |
| Lot Number | 619285 |
| 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, 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |