FDA Adverse Event
Injury
Summary report: N
OPTISTAR LE INJECTOR SYSTEM
MDR report key: 3124676
·
Received May 14, 2013
Report
- Report Number
- 1518293-2013-00112
- Event Type
- Injury
- Date Received
- May 14, 2013
- Date of Event
- May 8, 2013
- Report Date
- May 14, 2013
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- DXT
- PMA / PMN Number
- K073592
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FIELD SERVICE ENGINEER (FSE) VERIFIED PRESSURE LIMITS, FLOW RATE, AND PROPER OPERATION PER OPTISTAR LE SERVICE MANUAL AND COMPLETED SYSTEM CHECK OUT PER SERVICE CHECKLIST 802848. UNIT PASSED CHECKOUT PROCEDURES AND WAS RETURNED TO SERVICE.
Description of Event or Problem · 1
ON (B)(6) 2013, CUSTOMER REPORTS VIA PHONE THAT WHILE PERFORMING A BREAST SCAN ON A FEMALE PT OF UNKNOWN AGE AN EXTRAVASATION OCCURRED. THE TECHNOLOGIST STOPPED THE INJECTION BEFORE FINISHING THE INJECTION. THIS FACILITY USED A 22# BD ANGIOCATH, MALLINCKRODT Y TUBING, AND A 60 CC BD SYRINGE. THE INJECTION SITE HAD SOME SWELLING, BUT ONLY APPROXIMATELY 10 CC EXTRAVASATED. THE PT WAS TREATED WITH A WARM COMPRESS AND RELEASED. PERTINENT MEDICAL HISTORY: PT STATED SHE HAD FRAGILE VEINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 213894 | OPTISTAR LE INJECTOR SYSTEM | DXT | LIEBEL-FLARSHEIM CO. | OPTISTAR LE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |