MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-07 for BONE WAX 24X2.5G 1029754 manufactured by B.braun Surgical Sa.
[69566193]
(b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[69566194]
Country of complaint: (b)(6). It was reported that one open pouch with two packs of bone wax was inside one package. One of them was welded.
Patient Sequence No: 1, Text Type: D, B5
[73590232]
Samples received: 1 open pouch. Analysis and results: there are no previous complaints of this batch. Approx (b)(4) units were manufactured and distributed in the market, there are no units in stock. The open pouch received has two bone wax plates pouches inside, one of them welded. There are no previous complaints or this issue in the last five years, for this product. Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill b. Braun surgical requirements. We consider that this is an isolated and accidental unit that was not discarded in production line. Personnel involved has been warned about this issue. Actions on distributed product 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 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
| Report Number | 3003639970-2017-00091 |
| MDR Report Key | 6385242 |
| Date Received | 2017-03-07 |
| Date of Report | 2017-03-27 |
| Date of Event | 2017-02-06 |
| Date Facility Aware | 2017-02-10 |
| Date Mfgr Received | 2017-02-06 |
| Date Added to Maude | 2017-03-07 |
| 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 Phone | 3145515988 |
| Manufacturer G1 | B.BRAUN SURGICAL SA |
| Manufacturer Street | 121 CARRETERA DE TERRASSA |
| Manufacturer City | RUBI, BARCELONA 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 | BONE WAX |
| Product Code | MTJ |
| Date Received | 2017-03-07 |
| Returned To Mfg | 2017-03-02 |
| Model Number | 1029754 |
| Catalog Number | 1029754 |
| Lot Number | 216101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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, BARCELONA 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-07 |