MalfunctionBYR
SINGLE DISP TRANSPAC IV TRANSDUCER
Received Nov 8, 2001 · Event occurred Oct 1, 2001
Report 1713468-2001-00041 · MDR key 360620
Device
Generic name
Pressure Monitoring Kit
Manufacturer
Abbott LaboratoriesModel number
NACatalog number
42620
Lot number
UNK
Product problems
- Crack
- Leak/Splash
Patient
UNKNOWN
- No Consequences Or Impact To Patient
- Blood Loss
Narrative
Description of Event or Problem
REPORT RECEIVED FROM ABBOTT INTERNATIONAL AFFILIATE (ABBOTT JAPAN) OF A CRACKED TRANSDUCER WITH BLEED BACK. THE REPORT STATES: "IT WAS NOTICED THAT RUBBER OF SQUEEZE FLUSH HAD CRACKED AND BLOOD DIFFUSED IN FILLER SOLUTION. THERE IS NO HARM TO THE PT." ADDITIONAL INFO WAS REQUESTED, BUT NO FURTHER INFO WAS PROVIDED.