FDA Adverse Event
Other
Summary report: N
(CATH) CHEMO-CATH INTRODUCER
MDR report key: 501763
·
Received November 18, 2003
Report
- Report Number
- 2925153-2003-00011
- Event Type
- Other
- Date Received
- November 18, 2003
- Date of Event
- October 21, 2003
- Report Date
- October 31, 2003
- Manufacturer
- HDC CORP.
- Product Code
- DYB
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
"THE BLUE TIP OF INTRODUCER BROKE OFF IN PATIENT." NO ADDITIONAL INFORMATION IS AVAILABLE. NOR IS THERE INFORMATION OF WHETHER SURGICAL OR MEDICAL INTERVENTION WAS NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | (CATH) CHEMO-CATH INTRODUCER | CHEMO-CATHETER INTRODUCER | DYB | HDC CORP. | 334-09 | 0102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |