MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-15 for 1.9 FR ARGYLE DUAL LUMEN PICC 43304 manufactured by Covidien.
[142054782]
Customer reports that the primary lumen was found to be cracked during flushing. The baby did not lose a significant amount of blood and required a peripheral iv to be started to keep the tpn running. Patient was stable. The baby received an unnecessary poke for the iv.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00655 |
| MDR Report Key | 8514914 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-15 |
| Date of Report | 2019-06-06 |
| Date of Event | 2019-03-14 |
| Date Mfgr Received | 2019-03-19 |
| Date Added to Maude | 2019-04-15 |
| 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 | 1.9 FR ARGYLE DUAL LUMEN PICC |
| Generic Name | CATHETER, UMBILICAL ARTERY |
| Product Code | FOS |
| Date Received | 2019-04-15 |
| Model Number | 43304 |
| Catalog Number | 43304 |
| Lot Number | 1725600094 |
| 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 | 2019-04-15 |