FDA Adverse Event
Death
Summary report: N
TRAUMA KIT: 8.5 FR
MDR report key: 4964816
·
Received August 4, 2015
Report
- Report Number
- 1036844-2015-00345
- Event Type
- Death
- Date Received
- August 4, 2015
- Date of Event
- July 18, 2015
- Report Date
- July 28, 2015
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- DYB
- PMA / PMN Number
- K840455
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NO SAMPLE WILL BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THE TRAUMA SET WAS PLACED INTO THE PATIENT'S FEMORAL ARTERY. THE TUBING DISCONNECTED AND THE PATIENT "BLED OUT". THE PATIENT RECEIVED A BLOOD TRANSFUSION, CODED AND PASSED AWAY. A THIRD PARTY HAS BEEN CALLED IN TO INVESTIGATE BECAUSE "HUMAN ERROR" IS MOST LIKELY TO BLAME AND A THIRD PARTY IS MORE LIKELY TO BE UNBIASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 508672 | TRAUMA KIT: 8.5 FR | EMERGENCY/TRAUMA PRODUCTS | DYB | ARROW INTERNATIONAL INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |