FDA Adverse Event
Malfunction
Summary report: N
CARDINAL HEALTH
MDR report key: 13042782
·
Received December 20, 2021
Report
- Report Number
- 13042782
- Event Type
- Malfunction
- Date Received
- December 20, 2021
- Date of Event
- December 1, 2021
- Report Date
- December 8, 2021
- Manufacturer
- CARDINAL HEALTH 200, LLC
- Product Code
- OEQ
- 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
THE SKIN NEEDLE INSIDE THE CARDINAL HEALTH PRESOURCE PACK CARDIO MDHC, USED TO DELIVER SUBCUTANEOUS LIDOCAINE TO THE PATIENT, WAS DEFECTIVE WITHOUT A BEVELED TIP JUST BLUNT. IT WOULD HAVE BEEN EXTREMELY PAINFUL HAD THIS BEEN USED ON A PATIENT. THE SCRUB TECH NOTICED IT LOOKED DIFFERENT RIGHT BEFORE THE DOCTOR USED IT AND WAS ABLE TO GET A NEW ONE. THE CARDIO PACK WERE THE NEEDLE CAME FROM WAS LOT 622463 AND CATALOG SAN56CDMS3. IT WAS THE 27GX.5 NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1940710 | CARDINAL HEALTH | ANGIOGRAPHY/ANGIOPLASTY KIT | OEQ | CARDINAL HEALTH 200, LLC | SAN56CDMS3 | 622463 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29200 DA | Female |