Lot Number 3613156 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation: the returned sample was visually inspected at 12? to 16? and normal conditions of illumination according to the site visual inspection procedure.A damage was found on the surface of the cuff in both samples, thus the failure mode reported is confirmed.Cuff damage is usually due to the patient's anatomy or contact with a laryngoscope.The cuff damage resulting from patient anatomy will differ based upon the nature of intubation.The most probably root cause is the cuff got damaged during an insertion of the tracheostomy tube.No corrective action was required as there is no information to suggest that the product become damaged during manufacturing since product is 100% uson leak tested and each cuff shall be also tested by customer prior use.Dhr review was completed.Review of manufacturing records, relevant to the lot reported, found no discrepancies or anomalies.
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Event Description
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It was reported that during the use of the product, leakage of air from the cuff occurred in the two (2) products consecutively.The customer then checked the patient's trachea and tracheostomy aperture, but there found no factor that would lead to such an event.No patient injury was reported.
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Manufacturer Narrative
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Device evaluation: the returned sample was visually inspected at 12? to 16? and normal conditions of illumination according to the site visual inspection procedure.A damage was found on the surface of the cuff in both samples, thus the failure mode reported is confirmed.Cuff damage is usually due to the patient's anatomy or contact with a laryngoscope.The cuff damage resulting from patient anatomy will differ based upon the nature of intubation.The most probably root cause is the cuff got damaged during an insertion of the tracheostomy tube.No corrective action was required as there is no information to suggest that the product become damaged during manufacturing since product is 100% uson leak tested and each cuff shall be also tested by customer prior use.Dhr review was completed.Review of manufacturing records, relevant to the lot reported, found no discrepancies or anomalies.
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Event Description
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It was reported that during the use of the product, leakage of air from the cuff occurred in the two (2) products consecutively.The customer then checked the patient's trachea and tracheostomy aperture, but there found no factor that would lead to such an event.No patient injury was reported.
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Search Alerts/Recalls
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