FDA Adverse Event
Other
Summary report: N
8FR. STERILE VALVED INTRODUCER
MDR report key: 2536336
·
Received April 10, 2012
Report
- Report Number
- 1056436-2012-00031
- Event Type
- Other
- Date Received
- April 10, 2012
- Date of Event
- March 30, 2012
- Report Date
- April 9, 2012
- Manufacturer
- ANGIODYNAMICS
- Product Code
- DYB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
I HAD A COMPLAINT FROM (B)(6) HOSPITAL TODAY ABOUT THE VALVED ULTRASHEATHS 8 FRENCH. THE CATHETER WOULD NOT PASS THROUGH THE SHEATH AS IT HAS WITH EVERY OTHER SHEATH FROM US THAT THEY'VE USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8FR. STERILE VALVED INTRODUCER | INTRODUCER | DYB | ANGIODYNAMICS | NA | D1-01799 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |