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 2020-03-23 for COUPLER 5121-00400-060 manufactured by Baxter Healthcare Corporation.
[184448876]
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[184448877]
It was reported that a coupler had a bent metal tip (pin). This was further described as;? When the doctor opened the coupler and attached it to the applicator, it was noted that one of the metal tips was bent?. The doctor used another coupler to complete the procedure. This issue was identified during a surgical case. There was no patient injury or medical intervention associated with this event; the reporter stated "the patient is doing well". No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[188467817]
Additional information was added: the actual sample was received for evaluation. The jaw assembly was returned free floating in the bag along with the outer tray and inner tray and lid. The white protective holder for the jaw assembly was not returned. Visual inspection observed two (2) bent pins on the coupler ring seated in the right jaw assembly. The reported condition was verified. The cause of the condition could not be determined. A device history review revealed no issues that could have caused or contributed to the reported condition. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2020-01623 |
| MDR Report Key | 9865076 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | SYNOVIS SURGICAL INNOVATIONS |
| Manufacturer Street | 2575 UNIVERSITY AVE W |
| Manufacturer City | SAINT PAUL MN 55114 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55114 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COUPLER |
| Generic Name | DEVICE, ANASTOMOTIC, MICROVASCULAR |
| Product Code | MVR |
| Date Received | 2020-03-23 |
| Model Number | NA |
| Catalog Number | 5121-00400-060 |
| Lot Number | SP19G16-1385134 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |