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 2018-11-14 for MONOMAX VIOLET 2/0 (3) 70CM FR26 (M) B0041887 manufactured by B. Braun Surgical Sa.
[128401142]
(b)(4). Manufacturing site evaluation: samples received: there are no samples available. Analysis and results - there are no previous complaints nor units in our stock for the three possible batches (118142, 118143, and 118173). Without a sample, we cannot carry out a complete analysis. Nevertheless, we have tested the bending strength of needles available in stock of the same needle raw material batches, and the results fulfill the specification for these needles. In reviewing the batch manufacturing records of these products, there were no incidents related to these issues and the results during the process fulfilled requirements. Remarks: when working with monomax suture material, great care should be taken to avoid any crushing or crimping damage of the monofilament by instruments such as forceps or needle holders. Care should be taken to avoid damaging the needle when using the suture material. Always grasp the needle in a section 1/3 to 1/2 of the distance from the fiber attachment end to the needle point, and never at the end where the fiber is attached or the needle point. Grasping the needle at the area of its point could impair the penetration performance and cause a fracture of the needle. Grasping the needle close to the fiber attachment end could cause bending or breakage. Reshaping needles should be avoided and may result in a loss of their strength and resistance towards bending and breaking. Final conclusion - no samples were provided and testing could not be performed. Nevertheless, we take note of this incidence and if any sample is received in the future, the case will be re-opened and the product further analyzed.
Patient Sequence No: 1, Text Type: N, H10
[128401143]
It was reported that several times the sutures have broken during an operation causing longer operation time. It was noted that one case involved a c-section. Sometimes needles are broken and sometimes the inner package has stuck to the outer package. This report addresses the sutures that had broken. Additional information was not provided. All medwatch submissions related to this report are: 3003639970-2018-00735; 3003639970-2018-00736.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2018-00716 |
| MDR Report Key | 8070889 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-14 |
| Date of Report | 2018-11-14 |
| Date of Event | 2018-10-17 |
| Date Facility Aware | 2018-10-18 |
| Date Mfgr Received | 2018-10-18 |
| Date Added to Maude | 2018-11-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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, 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 2/0 (3) 70CM FR26 (M) |
| Generic Name | SYNTHETIC ABSORBABLE MONOFILAR |
| Product Code | NWJ |
| Date Received | 2018-11-14 |
| Model Number | B0041887 |
| Catalog Number | B0041887 |
| 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, 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-14 |