ADULT LUMBAR PUNCTURE TRAY 20X3 1/2
Received May 7, 2004
Report 1423507-2004-00044 · MDR key 558358
Device
Generic name
Procedure Tray
Manufacturer
Cardinal HealthModel number
4301CCatalog number
4301C
Lot number
L4A123
Product problems
- Fluid/Blood Leak
- Device Issue
Patient
UNKNOWN
- Surgical procedure aborted/stopped
Narrative
Description of Event or Problem
WHILE PT ON TABLE DOING PROCEDURE, THE SPINAL NEEDLE/HUB (DEFECTIVE), MATERIAL SPRAYED ALL OVER THE HUB. DR WAS HIGHLY UPSET. PT NOW HAS TO COME BACK TO DO PROCEDURE AGAIN. NO SAMPLE AVAILABLE DUE TO HIGH RADIATION LEVELS, IT WAS PUT IN DISPOSABLE UNIT. ADDITIONALLY, CONTACT STATED THEY WERE DOING A LP USING RADIOACTIVE DYE AND WHEN THE PHYSICIAN PUSHED ON THE SYRINGE, THE DYE SPRAYED ALL OVER. THEY DECIDED TO PROCEED WITH THE X-RAYS, AND THE DYE DID NOT ENTER THE PT'S SYSTEM AS DESIRED. THE DECISION TO ABORT THE PROCEDURE WAS MADE AT THAT TIME AND THE PT HAS BEEN RESCHEDULED. THE MEDICAL TEAM PERFORMING THE PROCEDURE DID NOT REQUIRE ANY ADD'L MEDICAL INTERVENTION AS A RESULT OF THE INCIDENT. BASED ON THE FACT THAT THE PT WILL REQUIRE A SECOND PROCEDURE THIS COMPLAINT WILL BE FILED WITH THE FDA.