FDA Adverse Event
Other
Summary report: N
CHEMO-CATH
MDR report key: 553469
·
Received November 4, 2004
Report
- Report Number
- 2925153-2004-00023
- Event Type
- Other
- Date Received
- November 4, 2004
- Report Date
- October 29, 2004
- Manufacturer
- HDC CORP.
- Product Code
- DQO
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CATHETER BROKE INTO SEVERAL PIECES DURING REMOVAL. CATHETER WAS COMPLETELY REMOVED FROM CENTRAL VEIN. THE CATHETER WAS DESCRIBED AS HARD AND NOT SOFT AS NORMALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHEMO-CATH | CHEMO-CATH 9.6 FR | DQO | HDC CORP. | 330-09 | 0130 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Other |