FDA Adverse Event
Malfunction
Summary report: N
CARDINAL HEALTH
MDR report key: 18334381
·
Received December 15, 2023
Report
- Report Number
- 18334381
- Event Type
- Malfunction
- Date Received
- December 15, 2023
- Date of Event
- October 19, 2023
- Report Date
- October 24, 2023
- Manufacturer
- CARDINAL HEALTH 200, LLC
- Product Code
- OIP
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DURING ONE OF OUR LUMBAR PUNCTURES, OUR PHYSICIAN ASSISTANT (PA) PICKED UP THE FOURTH VIAL TO COLLECT THE CSF. SHE NOTICED A BLACK FIBER ON THE CAP OF THE TUBE IN OUR STERILE TRAY. SHE DID NOT USE THIS TUBE TO COLLECT ANY CSF FROM THE PATIENT. THIS IS A CARDINAL HEALTH LUMBAR PUNCTURE TRAY, LOT# 132204.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2299784 | CARDINAL HEALTH | RADIOLOGY-DIAGNOSTIC KIT | OIP | CARDINAL HEALTH 200, LLC | 27-8920B | 132204 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |