MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-02-11 for COUPLER 5121-00400-010 manufactured by Baxter Healthcare Corporation.
[135725278]
The customer reported a potential lot number of gem2756 sp18b06-1270827. This lot number is not recognized by baxter. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[135725279]
It was reported that a pin on a coupler device was bent. This was identified when the surgeon took the coupler out of the package during set-up and preparation. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2019-00713 |
| MDR Report Key | 8325939 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-02-11 |
| Date of Report | 2019-03-13 |
| Date Mfgr Received | 2019-03-01 |
| Date Added to Maude | 2019-02-11 |
| 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 Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Street | NI NI |
| Manufacturer City | NI |
| 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 | 2019-02-11 |
| Returned To Mfg | 2019-02-14 |
| Model Number | NA |
| Catalog Number | 5121-00400-010 |
| Lot Number | ASKU |
| 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 | NI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-11 |