FDA Adverse Event
Malfunction
Summary report: N
DELTRAN PLUS NEEDLELESS ARTERIAL BLOOD COLLECTION SYSTEM
MDR report key: 1646962
·
Received March 8, 2010
Report
- Report Number
- 1646962
- Event Type
- Malfunction
- Date Received
- March 8, 2010
- Date of Event
- February 27, 2010
- Report Date
- March 8, 2010
- Manufacturer
- UTAH MEDICAL PRODUCTS, INC.
- Product Code
- DRS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TN, US
Narratives
Description of Event or Problem · 1
THIS REPORT INCLUDES THREE DIFFERENT INSTANCES OF THE FOLLOWING ISSUE. NURSE HAD FLUSHED THE TUBING, THEN ATTACHED THE TUBING TO THE UMBILICAL ARTERIAL LINE. BLOOD STARTED BACKING UP IN THE TUBING. THE NURSE THEN PROCEEDED TO FLUSH THE TUBING AND DURING THIS PROCEDURE, THE TUBING BROKE WHERE THERE IS A FIVE INCH PIECE OF TUBING ATTACHED AT THE END, WHICH IS NOT AT A CONNECTION (THIS IS WHERE THE BLOOD DRAW PORT IS LOCATED). APPROXIMATELY TWO (2) CC OF BLOOD LOSS OCCURRED; HOWEVER, NO HARM TO THE PATIENT.UTAH MEDICAL WAS CONTACTED AND REPLACED ALL THE CURRENT LOTS IN THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTRAN PLUS NEEDLELESS ARTERIAL BLOOD COLLECTION SYSTEM | MONITOR, BLOOD PRESSURE, TRANSDUCER | DRS | UTAH MEDICAL PRODUCTS, INC. | ABC-550NP | 1092386 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 DA | NO OTHER THERAPIES | ||
| 2 | 4 DA | |||
| 3 | 2 DA |