inforMED
MalfunctionFCE

AIRCON XL 3000 AIR CONTRAST KIT 3L

Received May 16, 2008

Report 9610849-2008-00015 · MDR key 1051370

Device

Generic name

Barium Enema Tip

Manufacturer

Covidien

Model number

AIR CONTRAST KIT

Catalog number

124072

Lot number

4264119

Product problems

  • Burst Container or Vessel

Patient

59 YR

  • No Information

Narrative

Additional Manufacturer Narrative

ROOT CAUSE IDENTIFIED: NO PRODUCT SAMPLE WAS NOT RECEIVED, THEREFORE NO INVESTIGATION COULD BE CARRIED OUT. CONCLUSIONS: THERE IS NO PREVIOUS COMPLAINT TO THIS ASSEMBLY PART NUMBER. CORRECTIVE ACTIONS: NO FORMAL CORRECTIVE ACTIONS WERE ASSIGNED DUE TO LACK OF PHYSICAL SAMPLE.

Description of Event or Problem

CUSTOMER REPORTS VIA PHONE: RETENTION BALLOON PREPPED ONCE, THEN POSITIONED. THE RETENTION BALLOON WAS GIVEN ONE SQUEEZE ON THE WHITE PILLOW. RETENTION CUFF BURST. SECOND RETENTION CUFF SYSTEM WAS THEN PREPPED ONCE. POSITIONED. RETENTION CUFF GIVEN 1 AND 1/2 SQUEEZES ON THE WHITE PILLOW. THE RETENTION CUFF BURST.