MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-12 for SILKAM BLACK 3/0 (2) 90CM HR26 C0765023 manufactured by B. Braun Surgical, S.a..
[183126892]
Analysis and results: there are no previous complaints of this code-batch. We manufactured and distributed in the market 720 units of this code-batch. There are no units in our stock. We have received 29 closed samples of the same code batch to analyze this complaint. We have tested the knot pull tensile strength of the samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 1. 22 kgf in average and 1. 18 kgf in minimum (ep requirements: 0. 92 kgf in average and 0. 31 kgf in minimum). Knot pull tensile strength results before releasing the product were 1. 16 kgf in average and 1. 13 kgf in minimum and fulfilled ep requirements. Additionally, we have also conduced the following tests: needle attachment strength of the samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 0. 78 kgf in average and 0. 62 kgf in minimum (ep requirements: 0. 69 kgf in average and 0. 35 kgf in minimum). Diameter result conducted on the silkam samples received is 0. 246 mm in average and fulfils the requirements of the european pharmacopoeia for this size and thread: 0. 200 mm < xave < 0. 249 mm. Diameter average value is in the high range of ep requirements for usp 3/0 size. The linear pull tensile strength of the samples received and the results are: 1. 86 kgf in average and 1. 82 kgf in minimum, and these results are correct and usual values for this thread and size. There are no european pharmacopoeia and united states pharmacopeia limits for this test. Remarks: when working with silkam 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. 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
[183126893]
It was reported that the thread breaks during surgery. Patient information is not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2020-00160 |
| MDR Report Key | 9824130 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-07-26 |
| Date Added to Maude | 2020-03-12 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILKAM BLACK 3/0 (2) 90CM HR26 |
| Generic Name | SILK SUTURE, STERILE |
| Product Code | GAP |
| Date Received | 2020-03-12 |
| Model Number | C0765023 |
| Catalog Number | C0765023 |
| Lot Number | 619305 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-12 |