FDA Adverse Event
Malfunction
Summary report: N
2 X 200ML SYRINGE W/60" Y-TUBING AND NO
MDR report key: 1051399
·
Received May 16, 2008
Report
- Report Number
- 9610849-2008-00012
- Event Type
- Malfunction
- Date Received
- May 16, 2008
- Report Date
- November 30, 2007
- Manufacturer
- COVIDIEN
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT HAS BEEN RETAINED BY THE CUSTOMER AND THE PRODUCT LOT NUMBER IS UNK. COVIDIEN PRODUCT MONITORING REQUESTED THAT THE CUSTOMER PLEASE RETAIN ANY FUTURE TUBING OR AT LEAST A LOT NUMBER IF THE EVENTS WERE TO REOCCUR.
Description of Event or Problem · 1
ON 12/10: CUSTOMER STATES, "STAFF FEELS THAT THE COILED TUBING IS NOT CONNECTING WELL WITH THE IV ACCESS ANGIOCATHS. TUBING BECOMES DISCONNECTED DURING INJECTIONS, AND INJECTIONS HAVE TO BE RESTARTED." THE COILED TUBING IS CONNECTED DIRECTLY TO THE IV ANGIOCATH, NO NEEDLE-LESS SYSTEM IS UTILIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2 X 200ML SYRINGE W/60" Y-TUBING AND NO | EXTENSION TUBING | FPA | COVIDIEN | EXTENSION TUBING | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |