FDA Adverse Event
Malfunction
Summary report: N
16" (41 CM) TRIFUSE ADD-ON SET W/3 BAG SPIKES, 3 CLAMPS (BLUE, 2 RED), PLUG ADAP
MDR report key: 8880732
·
Received August 9, 2019
Report
- Report Number
- 9617594-2019-00259
- Event Type
- Malfunction
- Date Received
- August 9, 2019
- Date of Event
- June 20, 2019
- Report Date
- July 17, 2019
- Manufacturer
- ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
- Product Code
- FMG
- UDI-DI
- 00840619062651
- PMA / PMN Number
- K964435
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT SAMPLES WERE RETURNED AND NO PHOTOGRAPHS OR VIDEOS WERE PROVIDED FOR INVESTIGATION. THEREFORE, A COMPREHENSIVE FAILURE INVESTIGATION WAS UNABLE TO BE PERFORMED AND A PROBABLE CAUSE CANNOT BE IDENTIFIED BASED ON THE INFORMATION PROVIDED. THE DHR LOT NUMBER REVIEW DID NOT IDENTIFY ANY NON CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT TRIFUSE ADD-ON SET WITH 3 BAG SPIKES LEAKED AT THE CONNECTION POINT TO THE IV LINE. THE LINE WAS FULLY INSERTED INTO THE TRIFUSE SET. THE PRODUCT WAS CONTAMINATED WITH A BIOHAZARD OR CHEMOTHERAPEUTIC AGENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, ADVERSE EVENT OR DELAY IN CRITICAL THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 675408 | 16" (41 CM) TRIFUSE ADD-ON SET W/3 BAG SPIKES, 3 CLAMPS (BLUE, 2 RED), PLUG ADAP | STOPCOCK, I.V. SET | FMG | ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. | 3962010 | 00840619062651 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |