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 2018-05-17 for BONE WAX 24X2.5G 1029754 manufactured by B.braun Surgical Sa.
[108754743]
(b)(4). Manufacturing site evaluation: samples received: none, pictures received showing the defect. Analysis and results: there are no previous complaints of this code batch of which (b)(4) units were manufactured and distributed in the market. There are no units in stock in the warehouse. No samples have been received but pictures attached shows a secondary packaging with a primary packaging without product. Between the different orders empty packages are driven to exclude a mixing with the respective orders. These empty units should be discarded by the personnel in production. Reviewed the batch manufacturing records this product had a normal process and results during process fulfilled the oem specifications. Taking into account that no other complaints have been received regarding this issue, it is considered that this is an isolated and accidental issue. Final conclusion: taking into account that the results of samples received do not fulfill the oem specifications, it is concluded that the complaint is justified. 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. This report is being submitted late due to mis-interpretation of 2 year presumption acknowledgement and agreement by fda. Once issue was identified, retrospective review of complaints was completed from time of 2 year presumption implementation to present. All reports identified are being reported.
Patient Sequence No: 1, Text Type: N, H10
[108754744]
Country of complaint: (b)(6). It is reported that there's no product inside the package.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2018-00278 |
| MDR Report Key | 7522958 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-17 |
| Date of Report | 2018-05-17 |
| Date Facility Aware | 2018-04-25 |
| Date Mfgr Received | 2018-01-23 |
| Date Added to Maude | 2018-05-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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 | BONE WAX 24X2.5G |
| Generic Name | BIOSURGICALS |
| Product Code | MTJ |
| Date Received | 2018-05-17 |
| Returned To Mfg | 2018-02-28 |
| Model Number | 1029754 |
| Catalog Number | 1029754 |
| Lot Number | 216271 |
| 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 | 1. Other | 2018-05-17 |