WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB NAVINA CONSUMABLE SET REGULAR; GASTROINTESTINAL TUBES AND ACESSORIES
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Model Number 69003 |
Device Problem
Product Quality Problem (1506)
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Patient Problem
Abdominal Pain (1685)
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Event Date 12/15/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This concerns a device from a manufactured lot, which has not been distributed to usa, but only distributed in europe.For this reason, the field safety corrective action and recall taken for this device and lot does not involve usa.The used rectal catheter regular involved in the event, (supplied within the consumable set regular) was not returned for investigation.Therefore, the manufacturer is precluded from establishing conclusions of the root cause behind this particular event.No further information is expected.It is however speculated the event could have been caused by a possible deficiency in the catheter's balloon material, since this had been identified for a few other catheters of the same lot, distributed to sites in europe.The lot with potential deficient catheters was subject to a recall, issued in europe in december 2018.The catheter involved in the event had been distributed before the manufacturer was aware of the quality issue and before issuing a recall notice to those countries where distributed.A root cause analysis and long term corrective and preventive action was implemented with immediate effect.
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Event Description
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A patient with previous medical history of a bowel perforation incident, when using another manufacturer's product for trans anal irrigation, reported pain and suspected balloon burst and damage to intestine when using the rectal catheter regular (supplied within the consumable set regular).The patient sought hospital care the day after.The health care provider did not consider it likely caused by the balloon burst.The patient had a contrast scan, but no physical damage was seen.The reporter stated the general diagnosis from the hospital and gps along with the bowel nurse, is that the inner wall of the intestine had been hurt.It was described by reporter as "not a full perforation and hard to see on the scans, but still a trauma".The patient informed she has been to the doctor's regularly since the event, and experience continued abdominal pain and discomfort, and had not healed at time of raising complaint.Treated with analgesic medication for pain and inflammation.Is not using the irrigation system since the event occurred.
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