FDA Adverse Event
Malfunction
Summary report: N
CONNECTOR TUBING BX 100
MDR report key: 2093405
·
Received April 12, 2011
Report
- Report Number
- 9610849-2011-00007
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- March 21, 2011
- Report Date
- March 22, 2011
- Manufacturer
- COVIDIEN
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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
ON (B)(6): CUSTOMER REPORTED VIA PHONE THAT DURING CT OF THE ABDOMEN THE LOW PRESSURE COILED TUBING RUPTURED, SPRAYING CONTRAST ON THE TECHNOLOGIST. OPTIRAY 100ML PREFILLED SYRINGE LOADED INTO THE INJECTOR SYSTEM. IV ACCESS WAS A 20GA ANGIOCATH. A BBRAUN ULTRASITE 7 INCH EXTENSION TUBE CONNECTED THE IV ACCESS DEVICE AND THE COVIDIEN COILED TUBING CONNECTED TO THE SYRINGE. INJECTION PROTOCOL WAS 2.5ML/SECOND FOR 100ML. AFTER APPROX 20ML OF CONTRAST WAS INJECTED, THE TUBING RUPTURED, SPRAYING CONTRAST ON THE STAFF. NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONNECTOR TUBING BX 100 | LOW PRESSURE CONNECTOR TUBING | FPA | COVIDIEN | CONNECTOR TUBING | 10810182 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |