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
CovidienModel number
AIR CONTRAST KITCatalog 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.