inforMED
MalfunctionIQE

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 Health

Model number

4301C

Catalog 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.