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 |