FDA Adverse Event
Malfunction
Summary report: N
HIGH PRESSURE TUBING IN A CUSTOM KIT
MDR report key: 1012501
·
Received March 12, 2008
Report
- Report Number
- 1721504-2008-00012
- Event Type
- Malfunction
- Date Received
- March 12, 2008
- Date of Event
- January 9, 2008
- Report Date
- February 15, 2008
- Manufacturer
- MERIT MEDICAL SYSTEMS, INC.
- Product Code
- BYX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL: ONE USED SAMPLE WAS RETURNED. VISUAL INSPECTION CONFIRMED THE FAILURE AS REPORTED. MEASUREMENTS WERE TAKEN ON THE MALE LUER TAPER AND IT WAS FOUND TO BE WITHIN SPECIFICATION. THE CUSTOMER COMPLAINT COULD BE CONFIRMED, HOWEVER, THE CAUSE OF THE ROTATOR BREAKING COULD NOT BE DETERMINED.
Description of Event or Problem · 1
THE ROTATOR BROKE AT THE HIGH PRESSURE TUBING DURING INJECTION ON A PT WITH HEPATITIS C. THERE WAS NO REPORTED INJURY TO THE PT OR THE CLINICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIGH PRESSURE TUBING IN A CUSTOM KIT | PRESSURE TUBING AND ACCESSORIES | BYX | MERIT MEDICAL SYSTEMS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | SYRINGE| CONTRAST |