FDA Adverse Event
Injury
Summary report: N
V-CATH
MDR report key: 380242
·
Received March 4, 2002
Report
- Report Number
- MW1024241
- Event Type
- Injury
- Date Received
- March 4, 2002
- Date of Event
- March 1, 2002
- Report Date
- March 4, 2002
- Manufacturer
- HDC
- Product Code
- DQO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PT DEVELOPED UPPER EXTREMITY SWELLING "NR" TO LINE; LINE DEVELOPED LEAK, VISIBLE HOLE/TEAR. WHEN NURSE ATTEMPTED TO DISCONTINUE LINE, LINE STRETCHED AND BROKE EXTERNALLY. PT SENT TO INTERVENTIONAL RADIOLOGY TO HAVE LINE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V-CATH | PICC, 5.0 FR. DUAL LUMEN | DQO | HDC | * | 1086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |