FDA Adverse Event
Injury
Summary report: N
OPTISTAR LE INJECTOR SYSTEM
MDR report key: 3124709
·
Received May 14, 2013
Report
- Report Number
- 1518293-2013-00111
- 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 LIVER SCAN ON A (B)(6) MALE PT AN EXTRAVASATION OCCURRED. THIS FACILITY USED A 22# BD ANGIOCATH, MALLINCKRODT Y TUBING, AND A 60 CC BD SYRINGE. THE PT HAD A HEMATOMA AT THE INJECTION SITE AND WAS SENT TO THEIR URGENT CARE WHERE PRESSURE WAS APPLIED TO SITE. HE WAS ALSO TREATED WITH A COLD COMPRESS, AND RELEASED WHEN HIS PAIN DISSIPATED. HIS ONLY PERTINENT MEDICAL HISTORY WAS A LOW PLATELET COUNT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 213729 | OPTISTAR LE INJECTOR SYSTEM | DXT | LIEBEL-FLARSHEIM CO. | OPTISTAR LE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | MALLINCKRODT Y TUBING |