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 2016-11-23 for BONE WAX 24X2.5G 1029754 manufactured by B.braun Surgical Sa.
[60869375]
(b)(4). Manufacturing site evaluation: samples received: 4 unopened units (each one of one different batch). Analysis and results: there are no previous complaints of any of the involved code-batches. Manufactured (b)(4) units of the batch 216034, (b)(4) units of the batch 215492, (b)(4) units of the batch 216104 and (b)(4) units of the batch 216102. There are no units in stock of any of the batches. Batch manufacturing records of the involved reference-batches have been checked and no deviations have been found. The following parameters of each sample received and other three different batches have been tested: smell, color, appearance, suppleness and adhesive behavior. All batches are into the current range for this product. No differences have been found between the different batches analyzed: the smell is the usual one, there is not smell rancid. The color is white yellow as usual. The appearance is according to the visual standard. Regarding the suppleness, the products can be kneaded well. Concerning the adhesive behavior, the product hold well on instruments. Final conclusion: complaint is not justified. Results of the samples received fulfills the oem requirements. Note is taken of this incident in order to assess if new or additional actions are needed. 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
[60869376]
Country of complaint: (b)(6). It was reported that there is a problem with the bone wax, the product crumbles upon use. The product does not stick well to the instruments and is not effective. All med watch submissions related to this report are: 2916714-2016-00960, 2916714-2016-00961, 2916714-2016-00962.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2016-00960 |
| MDR Report Key | 6125982 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-11-23 |
| Date of Report | 2016-11-17 |
| Date Facility Aware | 2016-11-04 |
| Date Mfgr Received | 2016-10-24 |
| Date Added to Maude | 2016-11-23 |
| 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 | 2016-11-23 |
| Returned To Mfg | 2016-10-31 |
| Model Number | 1029754 |
| Catalog Number | 1029754 |
| Lot Number | 215492 |
| 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, BARCELONA 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-23 |