FDA Adverse Event
Malfunction
Summary report: N
9FR PEEL-AWAY SHEATH INTRO KIT W/.038 GW
MDR report key: 2132424
·
Received June 14, 2011
Report
- Report Number
- 1219930-2011-00475
- Event Type
- Malfunction
- Date Received
- June 14, 2011
- Date of Event
- February 22, 2011
- Report Date
- May 17, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- LJS
- PMA / PMN Number
- K961856
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE SURGEON OPENED THE INTRODUCER PACKAGE AND FOUND THAT THE SHEATH WAS ALREADY SPLIT, AND COULD NOT BE USED. ANOTHER DEVICE WAS OPENED TO FINISH THE PORT IMPLANTATION PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9FR PEEL-AWAY SHEATH INTRO KIT W/.038 GW | CHEMOSITE INTRODUCER KIT | LJS | UNITED STATES SURGICAL | N9A100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |