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 2020-03-16 for SUPRAMID BLACK 4/0 (1.5) 75CM DS19 C0714208 manufactured by B.braun Surgical Sa.
[183664405]
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. K990090. Samples received: there are no samples available. Analysis and results: there are no previous complaints of the same code-batch. We manufactured and distributed in the market 2,088 units of this code-batch. There are no units in our stock. We have not received any sample for analysis. Without any samples we cannot carry out an analysis in order to take a decision. 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 on samples during the process were 0. 96 kgf in average and 0. 64 kgf in minimum and fulfilled the requirements of the european pharmacopoeia (ep requirements: 0. 46 kgf in average and 0. 23 kgf in minimum). Final conclusion: without samples we are not in position of studying if the affected product does not fulfil the specifications. In consequence, a proper analysis cannot be done and the case is not confirmed due to lack of evidence. Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyze it. Please note that when no samples are received our analysis is very limited. 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
[183664406]
It was reported that there is an issue with a needle detachment. The reporter indicated that the thread split from the needle. Additional information is not available. Patient information is not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2020-00130 |
| MDR Report Key | 9837256 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-03-16 |
| 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 | SUPRAMID BLACK 4/0 (1.5) 75CM DS19 |
| Generic Name | OTHER SUTURE |
| Product Code | GAR |
| Date Received | 2020-03-16 |
| Model Number | C0714208 |
| Catalog Number | C0714208 |
| Lot Number | 618521V030 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-16 |