MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-02 for COUPLER 5111-00250-060 manufactured by Baxter Healthcare Corporation.
[173340841]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[173340842]
It was reported that? The coupler portion (2. 5mm coupler) fell out of coupler device? ; this was further described as? When they picked it up to prepare for implantation the one ring on the coupler where the vessel is attached fell off?. This occurred during set up prior to use on the patient. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[177274213]
The actual sample was received for evaluation. The jaw assembly was returned free floating in the outer tray from the packaging. One ring was intact remaining in the right jaw of the assembly and the other ring was not returned. There were no signs of use on the one coupler ring that was in the jaw assembly returned for investigation. The reported condition was verified. The cause of the condition was not determined. A functional testing was not performed for this complaint. A device history review revealed no issues that could have caused or contributed to the reported issue. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2019-07294 |
| MDR Report Key | 9538618 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-02 |
| Date of Report | 2020-01-29 |
| Date of Event | 2019-11-19 |
| Date Mfgr Received | 2020-01-17 |
| Date Added to Maude | 2020-01-02 |
| 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 |
| 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 | 2020-01-02 |
| Returned To Mfg | 2019-12-16 |
| Model Number | NA |
| Catalog Number | 5111-00250-060 |
| Lot Number | SP19J29-1405751 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-02 |