FDA Adverse Event
Other
Summary report: N
1 X 200ML SYRINGE W/60" Y-TUBING AND
MDR report key: 1604245
·
Received February 9, 2010
Report
- Report Number
- 9610849-2010-00005
- Event Type
- Other
- Date Received
- February 9, 2010
- Date of Event
- February 8, 2010
- Report Date
- February 8, 2010
- Manufacturer
- COVIDEN
- Product Code
- DXT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
CUSTOMER REPORTS VIA PHONE, CT TECHNOLOGIST OPENED SYRINGE PACKAGE, NOTED THE BLUE CAP WAS ON THE LUER LOCK NUT, LOADED THE SYRINGE ONTO THE INJECTOR AND STARTED LOADING SALINE INTO THE SYRINGE. DURING THE PROCESS, TECHNOLOGIST NOTED A FOREIGN OBJECT FLOATING WITHIN THE SYRINGE. SYRINGE WAS REMOVED FROM THE INJECTOR AND SALINE EMPTIED. FOREIGN OBJECT SEEMS TO BE A PIECE OF PAPER. SYRINGE NOT USED FOR PATIENT PROCEDURE, NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1 X 200ML SYRINGE W/60" Y-TUBING AND | EMPTY DISPOSABLE SYRINGE | DXT | COVIDEN | 200ML DISP. SYR. | 9100266 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |