FDA Adverse Event
Injury
Summary report: N
V-CATH PICC
MDR report key: 394453
·
Received March 29, 2002
Report
- Report Number
- 2925153-2002-00004
- Event Type
- Injury
- Date Received
- March 29, 2002
- Date of Event
- February 7, 2002
- Report Date
- March 7, 2002
- Manufacturer
- HDC CORPORATION
- Product Code
- DQO
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PICC INSERTED IN 2002. REMOVED THE FOLLOWING MONTH, AND FOUND BROKEN. RADIOLOGY SAYS IT MUST HAVE BROKEN BEFORE, PROBABLY DURING SOME FLUSHING EXERCISE. THE TIP IS LODGED IN THE SOFT TISSUE OF THE MEDIASTINUM, AND THE REST OUT OF THE VASCULAR SYSTEM. THE REMOVED PIECE OF CATHETER HAS BEEN RETAINED BY RISK MANAGEMENT. PATIENT OK. NO ADDITIONAL ACTION BEING TAKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V-CATH PICC | 3 FR CATHETER | DQO | HDC CORPORATION | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |