FDA Adverse Event
Malfunction
Summary report: N
KWIKVIAL CONTAINER 15ML
MDR report key: 14211346
·
Received April 26, 2022
Report
- Report Number
- 3013445787-2022-00001
- Event Type
- Malfunction
- Date Received
- April 26, 2022
- Date of Event
- April 6, 2022
- Report Date
- April 6, 2022
- Manufacturer
- MEDSAFETY SOLUTIONS
- Product Code
- KYX
- UDI-DI
- 00853832007019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
COMPLAINT RECEIVED FROM PHARMACY SUPERVISOR THAT A SCREW WAS FOUND IN A SEALED KWIKVIAL CONTAINER. THE FOREIGN OBJECT WAS DETECTED PRIOR TO ADMINISTRATION. NO PATIENT INVOLVEMENT. THE CUSTOMER HAS BEEN REQUESTED TO FORWARD THE DEVICE FOR EVALUATION. PRELIMINARY INVESTIGATION SUGGESTS THAT THE SCREW WAS FROM MANUFACTURING EQUIPMENT USED TO PROCESS THE CONTAINERS. BATCH RECORD REVIEW WAS CONDUCTED; NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THIS TYPE OF INCIDENT WERE DESCRIBED. NO OTHER COMPLAINTS RELATED TO THIS TYPE OF INCIDENT HAVE BEEN REPORTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT A FOREIGN OBJECT WAS FOUND IN A KWIKVIAL CONTAINER. THE ISSUE WAS IDENTIFIED BEFORE USE. NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2365886 | KWIKVIAL CONTAINER 15ML | LIQUID MEDICATION DISPENSER | KYX | MEDSAFETY SOLUTIONS | 30015 | UNKNOWN | 00853832007019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |