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 2016-06-15 for MONOMAX VIOLET 1(4)150CM HRT48 LOOP(M B0041222 manufactured by B.braun Surgical Sa.
[47490536]
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. (b)(4). Manufacturing site evaluation: samples received: 3 unopened and 2 opened pouches. Analysis and results: there are no previous complaints of the same code-batch. Manufactured and distributed (b)(4) units of this code batch, there are no units in stock. Received three closed samples and two open samples (only the second pack is opened). Both open samples received have the first pack sealed to second pack in the 4th sealing. This defect took place in the welding machine and these units were not sorted out by the personnel involved in this process. On the other hand, all closed packs received were opened and the aluminum pouch was not stuck to the outer paper foil. All packs have been opened correctly. Final conclusion: complaint justified; taking into account that the open samples received does not fulfill the oem specifications. Actions on distributed product of this reference/batch: replace this code/batch to the customer or issue a refund. Corrective/preventive actions: this complaint will be included in the analysis of trending, and corrective action will be open if applies.
Patient Sequence No: 1, Text Type: N, H10
[47490537]
Country of complaint: (b)(6). Pouch sealed to 2nd pack.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2016-00480 |
| MDR Report Key | 5727505 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-06-15 |
| Date of Report | 2016-06-15 |
| Date Facility Aware | 2016-06-03 |
| Date Mfgr Received | 2016-05-20 |
| Date Added to Maude | 2016-06-15 |
| 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 1(4)150CM HRT48 LOOP(M |
| Generic Name | SUTURES |
| Product Code | NWJ |
| Date Received | 2016-06-15 |
| Returned To Mfg | 2016-06-01 |
| Model Number | B0041222 |
| Catalog Number | B0041222 |
| Lot Number | 114424 |
| Device Expiration Date | 2019-10-01 |
| 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 | 2016-06-15 |