FDA Adverse Event
Other
Summary report: N
V-CATH
MDR report key: 474875
·
Received July 25, 2003
Report
- Report Number
- 2925153-2003-00006
- Event Type
- Other
- Date Received
- July 25, 2003
- Date of Event
- January 1, 2003
- Report Date
- July 1, 2003
- Manufacturer
- HDC CORP.
- Product Code
- DQO
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
FIRST REPORTED AS "FAULTY PRODUCT". ADDITIONAL INFO NOW STATES THE LINE WAS REMOVED AFTER 14 DAYS OF AUGMENTIN (AMOXACILLN AND CLAVULANIC ACID) "1 GRAM 8 HOURLY". DURING EACH ADMINISTRATION THE LINK WAS FLUSHED WITH NORMAL SALINE AND LOCKED OFF WITH 3 MLS OF HEPARINIZED SALINE, 10 UNITS / ML. THE NURSE MEASURED THE PICC AFTER REMOVAL AND REALIZED 5CM HAD BROKEN OFF. THE PT WAS TAKEN TO THEATER AND 5CM OF CATHETER WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V-CATH | PICC CATHETER | DQO | HDC CORP. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |