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 2020-03-27 for 1.9F ARGYLE SINGLE LUMEN PICC 43303 manufactured by Covidien.
| Report Number | 3009211636-2020-00694 |
| MDR Report Key | 9891594 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-03-17 |
| Date Added to Maude | 2020-03-27 |
| 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 | 1.9F ARGYLE SINGLE LUMEN PICC |
| Generic Name | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS |
| Product Code | LJS |
| Date Received | 2020-03-27 |
| Model Number | 43303 |
| Catalog Number | 43303 |
| Lot Number | 11260110 |
| 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 | 2020-03-27 |