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 2016-03-09 for MONOMAX VIOLET 0 (3,5) 150CM HR26 (M) B0041441 manufactured by B.braun Surgical Sa.
[39985437]
Reported device not marketed in the u. S. , however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device registered within the u. S. Manufacturing site evaluation: samples received: there are no samples available or batch number. Analysis and results: as no batch number is available, the batch manufacturing record cannot be reviewed. Without any closed and/or defective sample a proper analysis can not be performed. We need defective samples showing the defect to asses properly the customer complaint. There is an improvement project in course in order to minimize/reduce and avoid this defect. (b)(4) units were manufactured and distributed of this code batch, there are no units in stock. Without any closed samples a study cannot be performed to determine if the product fulfills the oem requirements. Final conclusion: complaint is not justified. Without samples a study can not be performed to see if the affected product does not fulfill the oem requirements. Note is taken of this incidence and if any samples are received in the future, the case will be re-opened and analyzed. Please note that when no samples are received analyzing is very limited. Actions on product: based on the conclusion derived from investigation, it is not required to take an action on distributed product. Corrective/preventive actions: according to the internal procedures, there is no need to establish corrective or preventive actions. This complaint is recorded for trending analysis to assess if actions are needed in the future. Device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[39985438]
Country of complaint: (b)(4). Inner foil is welded with outer foil. Steril withdrawal is not guaranteed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2016-00161 |
| MDR Report Key | 5489595 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-03-09 |
| Date of Report | 2016-03-09 |
| Date of Event | 2016-02-11 |
| Date Facility Aware | 2016-02-26 |
| Date Mfgr Received | 2016-02-12 |
| Date Added to Maude | 2016-03-09 |
| 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 | MONOMAX VIOLET 0 (3,5) 150CM HR26 (M) |
| Generic Name | SUTURES |
| Product Code | NWJ |
| Date Received | 2016-03-09 |
| Model Number | B0041441 |
| Catalog Number | B0041441 |
| Lot Number | N/A |
| 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, BARCELONA 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-09 |