FDA Adverse Event
Other
Summary report: N
V-CATH
MDR report key: 552893
·
Received November 2, 2004
Report
- Report Number
- 2925153-2004-00022
- Event Type
- Other
- Date Received
- November 2, 2004
- Date of Event
- October 29, 2004
- Report Date
- November 2, 2004
- Manufacturer
- HDC CORP.
- Product Code
- DQO
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE PICC WAS INSERTED AT 4 WEEKS AGO. IN 10, THE CATHETER WAS LEAKING AT THE END OF THE HUB (TUBING JOINS MOLDING HUB) ON THE FOLLOWING DAY, AN ATTEMPT WAS MADE TO REPLACE THE CATHETER BY USING AN INTRODUCER AND THEN PULLED THE CATHETER BACK. THE CATHETER SNAPPED OFF AND CURLED UP AT THE INSERTION SITE. CATHETER DID NOT MIGRATE INTO THE PT. IMMEDIATELY A TOURIQUET WAS PLACED ON PT'S LEFT ARM AND CATHETER WAS SUCCESSFULLY REMOVED VIA FLUOROSCOPY. PT IS FINE. THERE WAS NO HARM OR INJURY INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V-CATH | 4FR SELDINGER V-CATH | DQO | HDC CORP. | 400-166 | 1042A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |