FDA Adverse Event
Malfunction
Summary report: N
STERILCONTAINER FILTER
MDR report key: 17271541
·
Received July 6, 2023
Report
- Report Number
- 1319130-2023-00008
- Event Type
- Malfunction
- Date Received
- July 6, 2023
- Report Date
- July 6, 2023
- Manufacturer
- SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.
- Product Code
- KCT
- UDI-DI
- 04038653473731
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CROSSTEX SPSMEDICAL HAS REQUESTED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, TO DATE, ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED. THE STERILCONTAINER FILTERS WERE NOT RETURNED TO CROSSTEX SPSMEDICAL FOR EVALUATION. WITHOUT THE RETURNED DEVICE, A ROOT CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW-UP MDR WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.
Description of Event or Problem · 0
THE USER FACILITY REPORTED THAT THE INDICATOR DOT ON THEIR STERILCONTAINER FILTER DID NOT PRODUCE A UNIFORM COLOR FOLLOWING A COMPLETED CYCLE RESULTING IN A PROCEDURE DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 498693 | STERILCONTAINER FILTER | STERILCONTAINER FILTER | KCT | SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. | US751 | 04038653473731 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |