FDA Adverse Event
Malfunction
Summary report: N
MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2
MDR report key: 2150533
·
Received June 22, 2011
Report
- Report Number
- 2242445-2011-00080
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 20, 2011
- Manufacturer
- ARROW INTL., INC
- Product Code
- FOZ
- PMA / PMN Number
- K071538
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CATHETER WAS INSERTED INTO THE RIGHT INTERNAL JUGULAR OF A FEMALE PT. THE CATHETER WAS IN PLACE FOR APPROX 5 DAYS. WHEN THE PT WAS MOVING FROM A CHAIR NEXT TO THE BED, THE HUB OF THE CATHETER BROKE. THERE WAS NOTHING THAT WAS PULLING ON THE CATHETER THAT WOULD HAVE MADE THIS OCCUR. AS A RESULT, THE LINE WAS CLAMPED IMMEDIATELY AND THE CATHETER WAS EXCHANGED. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED. THE PT OUTCOME WAS GOOD. NO SURGICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFO RECEIVED ON (B)(6) 2011 FROM THE SALES REP STATED THAT THEY USE ALCOHOL SWABS TO CLEAN THE CATHETER HUBS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2 | ARROWG+ARD CATHETER PRODUCTS. | FOZ | ARROW INTL., INC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |