Catalog Number AB6318 |
Device Problems
Inflation Problem (1310); Failure to Deflate (4060); Unintended Deflation (4061)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2023 |
Event Type
malfunction
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Event Description
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According to available information, this device required replacement due to difficult inflation.The device was difficult to inflate and impossible to deflate.The device eventually self-deflated.The balloon was intact after device removal.It is suspected that the problem was with the valve.No other adverse patient effects were reported.
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Manufacturer Narrative
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Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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Manufacturer Narrative
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After receiving this complaint, we searched for other complaints and found none on the lot 9018842.Checking the quality databases revealed one corrective and preventive action are ongoing documentary investigation was performed about this lot, no issue were registered during production.On august we received one used sample.After disinfection, medical device was tested.The balloon can be inflated with water but the valve is leaking and the green piston inside the valve is askew and seems to be pushed in.On 27th october, we received the investigation from our subcontractor : the cause of the defect is a valve problem (offset piston).
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Event Description
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According to available information, this device required replacement due to difficult inflation.The device was difficult to inflate and impossible to deflate.The device eventually self-deflated.The balloon was intact after device removal.It is suspected that the problem was with the valve.No other adverse patient effects were reported.
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Search Alerts/Recalls
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