FDA Adverse Event
Malfunction
Summary report: N
ILLUMENIA-SYR-W/HF-150ML (LINDEN LUER)
MDR report key: 1873645
·
Received September 21, 2010
Report
- Report Number
- 9610849-2010-00015
- Event Type
- Malfunction
- Date Received
- September 21, 2010
- Report Date
- August 25, 2010
- Manufacturer
- COVIDIEN
- Product Code
- DXT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 REPORTS VIA PHONE, DURING CEREBRAL ANGIOGRAPHY PROCEDURE, THE TIP OF THE LUER LOCK NUT HAS BROKEN OFF, ALLOWING THE HIGH PRESSURE TUBING TO DETACH AND SPRAY CONTRAST. INJECTION PROTOCOL; 20ML/SEC FOR 40ML VOLUME, 900PSI. MERIT MEDICAL HIGH PRESSURE TUBING CONNECTED TO THE SYRINGE, 5FR PIGTAIL CATHETER CONNECTED TO THE HP TUBING. CUSTOMER DID NOT PROVIDE PT INFO, OTHER THAN TO SAY NO BODY WAS INJURED, ALL STAFF WEARS PERSONAL PROTECTION GEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ILLUMENIA-SYR-W/HF-150ML (LINDEN LUER) | EMPTY DISPOSABLE SYRINGE | DXT | COVIDIEN | 150ML DISP SYR | 0141214 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |