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 2016-09-02 for MONOMAX VIOLET 0 (3,5) 150CM HR26 (M) B0041441 manufactured by B.braun Surgical Sa.
[53900359]
(b)(4). Manufacturing site evaluation: samples received: 7 unopened and 1 open pouches. Analysis and results: there are no previous complaints of this code batch. (b)(4) units were manufactured and distributed of this code batch, there are no units in stock. The open sample received had only the second pack opened, but it was not attached/glued to the first pack. However, there are signs that the first and second packs were sealed together. The 7 unopened pouches received have been opened and none of them had the aluminum pouch (first pack) sealed/stuck to the foil (second pack). All packs have been opened correctly. Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfills the oem requirements. Final conclusion: complaint is not justified. This is considered an isolated unit. Note of this incidence is taken in order to assess if new or additional actions are needed. 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.
Patient Sequence No: 1, Text Type: N, H10
[53900360]
Country of complaint: (b)(6). It is reported that the inner foil is sealed to the outer foil and sterile withdrawal from pouch can not be guaranteed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2016-00715 |
| MDR Report Key | 5925040 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-09-02 |
| Date of Report | 2016-08-31 |
| Date of Event | 2016-07-28 |
| Date Facility Aware | 2016-08-10 |
| Date Mfgr Received | 2016-08-05 |
| Device Manufacturer Date | 2016-01-08 |
| Date Added to Maude | 2016-09-02 |
| 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 | 2016-09-02 |
| Returned To Mfg | 2016-08-10 |
| Model Number | B0041441 |
| Catalog Number | B0041441 |
| Lot Number | 116015V004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 8 MO |
| 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 | 2016-09-02 |