Model Number IPN028485 |
Device Problem
Disconnection (1171)
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Patient Problems
Distress (2329); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that during use on patient, "connections are not secure between chest drain catheter and the drainage tube.The drainage tube will spontaneously disconnect from the catheter".As a result, the "staff have taped the connections or used cable ties".The issue occurred while the patient was lying in bed.No patient harm or injury.The patient status is reported as "stable and discharged home".
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Manufacturer Narrative
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(b)(4).The additional information received on 29sep2023 reported that the patient had an oesophagectomy.Chest drain was placed on suction to resolve pneumothorax.The customer complaint cannot be confirmed based on the photos provided and complaint verification testing could not be performed as no sample was returned for analysis.One photo was received for analysis.A catheter that was not part of product s-1102-08lf (pe sahara dry suct/dry seal dual lf 6) was observed.No other issues were observed.A device history record (dhr) review was conducted for the lot number with no relevant findings.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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It was reported that during use on patient, "connections are not secure between chest drain catheter and the drainage tube.The drainage tube will spontaneously disconnect from the catheter".As a result, the "staff have taped the connections or used cable ties".The issue occurred while the patient was lying in bed.No patient harm or injury.The patient status is reported as "stable and discharged home".
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Search Alerts/Recalls
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