MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-03-29 for 5.0FR URETHANE UMB CATH 8888160341 manufactured by Covidien.
[140329672]
Additional information has been requested but to day no further details have been provided. The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Patient Sequence No: 1, Text Type: N, H10
[140329673]
The customer reports the uvc is leaking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00652 |
| MDR Report Key | 8465060 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-29 |
| Date of Report | 2019-08-01 |
| Date of Event | 2019-03-26 |
| Date Mfgr Received | 2019-03-26 |
| Date Added to Maude | 2019-03-29 |
| 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 Contact | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5086183640 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | EDIFICIO B20 CALLE #2 ZONA FRA |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5.0FR URETHANE UMB CATH |
| Generic Name | CATHETER, UMBILICAL ARTERY |
| Product Code | FOS |
| Date Received | 2019-03-29 |
| Model Number | 8888160341 |
| Catalog Number | 8888160341 |
| Lot Number | 1803800115 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | EDIFICIO B20 CALLE #2 ZONA FRA ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-29 |