FDA Adverse Event
Malfunction
Summary report: N
CARDINAL HEALTH
MDR report key: 17660419
·
Received August 31, 2023
Report
- Report Number
- 17660419
- Event Type
- Malfunction
- Date Received
- August 31, 2023
- Date of Event
- April 5, 2023
- Report Date
- August 14, 2023
- Manufacturer
- CARDINAL HEALTH 200, LLC
- Product Code
- OJH
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
INCORRECT SPONGE COUNT IN PRESOURCE LOCAL HAND PACK 6 LONGS DISCOVERED AT INITIAL COUNT PACK INFO: LOCAL HAND PACK SOPOCLHSRA EXP DATE [REDACTED DATE] MFG DATE [REDACTED DATE] LOT# 991467, CATALOG SOPOCLHSRA. ITEM WAS DISCARDED AFTER THE CASE PER THE SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1390036 | CARDINAL HEALTH | ORTHOPEDIC TRAY | OJH | CARDINAL HEALTH 200, LLC | SOPOCLHSRA | 991467 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |