FDA Adverse Event
Malfunction
Summary report: N
TRAUMA KIT: 8.5 FR
MDR report key: 3130213
·
Received May 22, 2013
Report
- Report Number
- 3006425876-2013-00090
- Event Type
- Malfunction
- Date Received
- May 22, 2013
- Date of Event
- April 25, 2013
- Report Date
- May 20, 2013
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- DQY
- PMA / PMN Number
- K840455
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS DISCARDED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PHYSICIAN THAT THERE HAVE BEEN A COUPLE OF MISHAPS USING THE TRAUMA KIT. HE THINKS IT IS PARTLY HUMAN ERROR AND THE LINE IS TOO SHORT. THE LINE MIGRATED OUT SO BLOOD AND FFP (FRESH FROZEN PLASMA) WAS INFUSED INTO THE CHEST AND CAME OUT THROUGH THE CHEST DRAIN. THE LINE HAD KINKED AND THEY COULD NOT ASPIRATE BLOOD BACK AND THEY TESTED THE POSITION OF THE LINE WITH A SMALL DOSE OF ADRENALINE TO CHECK IF THE TIP WAS IN THE CORRECT PLACE AND IT HAD MIGRATED OUT. THERE WERE NO PATIENT COMPLICATIONS. THE PHYSICIAN STATES THAT THE PATIENTS SURVIVED AND ARE FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 227361 | TRAUMA KIT: 8.5 FR | THORACIC CATHETER PRODUCTS | DQY | ARROW INTERNATIONAL INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |