FDA Adverse Event
Other
Summary report: N
MICROBORE EXTENSION SET WITH LOCKING SPIN COLLAR T AND PREPI
MDR report key: 551158
·
Received October 21, 2004
Report
- Report Number
- 551158
- Event Type
- Other
- Date Received
- October 21, 2004
- Date of Event
- July 1, 2004
- Report Date
- September 1, 2004
- Manufacturer
- HOSPIRA GLOBAL MEDICAL AFFAIRS
- Product Code
- FPA
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING CARDIAC CASE, ANESTHESIA USED 22 GAUGE, IV, INTERVENOUS, CATHETER WHICH WAS CONNECTED TO A T PIECE FOR THE PT. AFTER CLOSURE OF STERNUM, AIR WAS SEEN IN THE RIGHT VENTRICULAR CAVITY AND MYOCARDIUM. ANESTHESIOLOGIST IMMEDIATELY CHECKED ALL THE BLOOD PRODUCTS BEING GIVEN, TECHNIQUE OF GIVING BLOOD PRODUCTS, IV TUBING AND ALL THE CONNECTIONS. NO OBVIOUS DEFECTS NOTED. ANESTHESIOLOGIST DID NOTICE THAT EVEN THOUGH THE LUER-LOCK OF THE T PIECE WAS TIGHT, THE NEEDLELESS HUB FOR INJECTING THE MEDICATIONS SEEMED LOOSE. T PIECE CONNECTOR WAS IMMEDIATELY CHANGED AND PRODUCTS CONTINUED TO BE GIVEN THROUGH THE SAME IV. NO FURTHER AIR IN THE HEART SEEN ON ECHOCARDIOGRAM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROBORE EXTENSION SET WITH LOCKING SPIN COLLAR T AND PREPI | ADMINISTRATION SET | FPA | HOSPIRA GLOBAL MEDICAL AFFAIRS | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Other | FUNCTION.| NOT KNOWN. PT WAS UNDERGOING CARDIAC SURGERY AND| ECHOCARDIOGRAPHY, PROBE USED TO MONITOR CARDIAC| WAS UNDER GENERAL ANESTHESIA. TEE, TRANSESOPHAGEAL |