FDA Adverse Event
Injury
Summary report: N
V-CATH
MDR report key: 189917
·
Received September 29, 1998
Report
- Report Number
- 2925153-1998-00014
- Event Type
- Injury
- Date Received
- September 29, 1998
- Date of Event
- August 14, 1998
- Report Date
- September 23, 1998
- Manufacturer
- HDC CORP.
- Product Code
- DQO
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THIS IS A F/U REPORT TO MDR#2925153-1998-00013. OF THE 5 INITIALLY REPORTED EVENTS ONLY ONE (1) REPORT WAS CONFIRMED TO BE AN MDR REPORTABLE EVENT. THIS EVENT IS DESCRIBED AS: PICC LINE BROKE OFF - NEED CUT DOWN FOR REMOVAL. PROCEDURE: A SKIN INCISION WAS MADE OVER THE PALPABLE CATHETER. VEIN WAS DISSECTED PROXIMALLY & DISTALLY. A TRANSVERSE VENOTOMY WAS MADE AND RETAINED PICC CATHETER WAS IDENTIFIED. IT WAS REMOVED. THE USER FACILITY FILED TO THE MFR ON 09/22/98 AFTER REPEATED REQUESTS BY THE MFR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V-CATH Implant | CATHETER (PICC) | DQO | HDC CORP. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |