FDA Adverse Event
Malfunction
Summary report: N
9CM STRAIGHT HEMOSPLIT MI KIT WITH AIRGUARD
MDR report key: 3111573
·
Received May 6, 2013
Report
- Report Number
- 3006260740-2013-00204
- Event Type
- Malfunction
- Date Received
- May 6, 2013
- Date of Event
- February 25, 2013
- Report Date
- April 11, 2013
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- MSD
- PMA / PMN Number
- K030020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.
Description of Event or Problem · 1
IT WAS REPORTED THAT ON (B)(6) 2012 A CATHETER WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2013, THE PATIENT FOUND BLOOD EXUDATION AROUND THE SKIN AND CATHETER. HE WENT TO THE HOSPITAL AND THE DOCTOR FOUND THE CATHETER OUT OF THE POSITION 3CM. THE CUFF STILL IN HIS BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 196057 | 9CM STRAIGHT HEMOSPLIT MI KIT WITH AIRGUARD | MSD | C. R. BARD INC. (BASD) | REVG1020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention |