FDA Adverse Event
Malfunction
Summary report: N
SECURE
MDR report key: 11814890
·
Received May 12, 2021
Report
- Report Number
- 1937141-2021-00004
- Event Type
- Malfunction
- Date Received
- May 12, 2021
- Report Date
- July 27, 2021
- Manufacturer
- THE METRIX COMPANY
- Product Code
- KPE
- UDI-DI
- 50812496011577
- PMA / PMN Number
- K030888
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PARTICULATE WAS FOUND IN 3 TO POSSIBLY 10 UNITS OF THE SECURE 50 ML 2 PORT EVA BAGS, LOT 66043-A6929. LATER IT WAS REPORTED AN ADDITIONAL 3 UNITS WERE IDENTIFIED WITH PARTICULATE. THE PARTICULATE WAS NOTED BY THE SAME PHARMACY UPON INSPECTION AFTER THE BAGS WERE FILLED. THERE IS NO REPORT OF PATIENT INJURY OR DEATH. THE PARTICULATES ARE IN THE PROCESS OF BEING ANALYZED BY A THIRD PARTY LABORATORY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 712204 | SECURE | 50ML 2 PORT EVA BAG | KPE | THE METRIX COMPANY | 66043 | 66043-A6929 | 50812496011577 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |