MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2019-05-30 for UVC TRAY/5.0 FR PU 8888160432 manufactured by Covidien.
[146536863]
Additional information and the incident sample have been requested but to date have 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.
Patient Sequence No: 1, Text Type: N, H10
[146536864]
The customer reported the umbilical artery catheter was placed in a one day old male patient weighing (b)(6) grams. The ivfs were attached and transducing appropriate waveform and bp. Lab was drawn from uac at the stopcock connection without incidence. There was good blood return and it flushed easily. Approximately 20 minutes later, the line began to back up blood and it was noted that there was leaking from a crack in the line near the hub. The line was clamped to prevent blood loss and the medical doctor was notified. The catheter was removed by the medical doctor and replaced with a new umbilical catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00658 |
| MDR Report Key | 8655088 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2019-05-30 |
| Date of Report | 2019-10-08 |
| Date of Event | 2019-04-29 |
| Date Mfgr Received | 2019-05-28 |
| Date Added to Maude | 2019-05-30 |
| 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 | UVC TRAY/5.0 FR PU |
| Generic Name | CATHETER, UMBILICAL ARTERY |
| Product Code | FOS |
| Date Received | 2019-05-30 |
| Model Number | 8888160432 |
| Catalog Number | 8888160432 |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-05-30 |