inforMED
MalfunctionKDQ

ONE-VAC¿

Received Jul 13, 2026 · Event occurred Jun 16, 2026

Report 25794635 · MDR key 25794635

Device

Generic name

Bottle, Collection, Vacuum

Model number

00884450749609

Catalog number

EVAC1000/A

Lot number

(10)L3492950

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PERFORMED PARACENTESIS W/SAFETY-CENTESIS KIT. ASCITES FLUID REMOVED WITH THE CATHETER IN THE APPROPRIATE SPACE, CONFIRMED WITH ULTRASOUND. HOWEVER, ATTEMPTS TO USE NEW VACUTAINERS WERE UNSUCCESSFUL. SUCTION APPEARED INITIALLY ADEQUATE ON ATTACHMENT BUT THEN WOULD RAPIDLY TAPER TO A SLOW TRICKLE. OBSERVED INCREASED AIR BUBBLE FORMATION IN THE LINE WITH A CONCURRENT DROP IN SUCTION. CONNECTIONS CHECKED MULTIPLE TIMES AND WERE FOUND SECURE. VALVE WAS NOT TWISTED BEYOND STOP POINT. ATTEMPTED REPLACEMENT OF VACUTAINER AND COULD HEAR AIR HISS ON DISCONNECT THAT WOULD INDICATE SUCTION WAS STILL PRESENT. THE EXACT SAME SCENARIO RECURRED WITH EACH BOTTLE EXCHANGE AND AN OVERT LOSS OF SUCTION. NEXT, ATTEMPTED TO EXCHANGE TUBE FROM THE INSERTED CATHETER TO THE VACUTAINER AND THE SAME ISSUE RECURRED WITH OVERT LOSS OF SUCTION. ULTIMATELY REQUIRED TO PISTON SYRINGE SEVERAL MLS OF ASCITIC FLUID FROM THE PATIENT BUT THERE WAS STILL A SUBSTANTIAL AMOUNT OF VOLUME THAT REMAINED AND WAS UNABLE TO BE REMOVED FROM WITHIN THE SPACE. THE PROCEDURE WAS ABORTED WITH VERY MINIMAL VOLUME REMOVED S/P MULTIPLE ATTEMPTS TO TROUBLE SHOOT THE ISSUE. THIS DID NOT HAVE A CLINICAL EFFECT OR HARM THE PATIENT AS THEY CONTINUED WITH OTHER THERAPEUTIC PARAS AFTERWARDS.