MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-08-17 for PICC * UNK manufactured by C.r. Bard, Inc.(basd).
[20198018]
In 2005 the picc was placed. X-ray taken and it showed proper in placement. Pt also has a trachea tube and coughs a lot. In 2005, during treatment, the rn noticed swelling in the pt's neck. Pt was sent for ct scan and it showed the catheter had disloaded and perforated the ij. Pt's status is okay because they caught it early.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1720496-2005-00138 |
| MDR Report Key | 701364 |
| Report Source | 06 |
| Date Received | 2005-08-17 |
| Date of Report | 2005-07-28 |
| Date Mfgr Received | 2005-07-28 |
| Date Added to Maude | 2006-04-21 |
| 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 | NITIN PATIL |
| Manufacturer Street | 5425 S AMELIA EARHART DR |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015950700 |
| Manufacturer G1 | UNK |
| Manufacturer Street | UNK |
| Manufacturer City | UNK |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PICC |
| Generic Name | IMPLANTED LONG TERM INTRAVASCULAR |
| Product Code | LGS |
| Date Received | 2005-08-17 |
| Model Number | * |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 690472 |
| Manufacturer | C.R. BARD, INC.(BASD) |
| Manufacturer Address | * SALT LAKE CITY UT * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-08-17 |