FDA Adverse Event
Malfunction
Summary report: N
EXACTA
MDR report key: 178701
·
Received July 22, 1998
Report
- Report Number
- 2529252-1998-00001
- Event Type
- Malfunction
- Date Received
- July 22, 1998
- Report Date
- June 24, 1998
- Manufacturer
- THOMAS MEDICAL PRODUCTS INC.
- Product Code
- DYB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
A PROCEDURE WAS BEING PERFORMED USING A PERCUTANEOUS INTRODUCER KIT, WHICH IS SUPPLIED BY BECTON DICKINSON, WHEN PROBLEMS WERE ENCOUNTERED WITH A THOMAS MEDICAL PROD. INC. MFR PERCUTANEOUS SHEATH INTRODUCER AND A TELEFLEX INC. SUPPLIED GUIDEWIRE. THE REPORT DESCRIBES THE TROUBLE AS: (1) GUIDEWIRE SPLIT AND FRAYED INSIDE. (2) PLASTIC VALVE CAME LOOSE OUT OF HEMOSTASIS IS VALVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXACTA | PERCUTANEOUS INTRODUCER | DYB | THOMAS MEDICAL PRODUCTS INC. | PERCUTANEOUS INTRODUCER | F17867 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |