Model Number IPN040141 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that "the doctor found tube blocked when using on patient.Then changed new one, no impact on patient." at the time of this report, the customer has not returned our requests for additional information.The complaint file will be updated if further information is received.
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Manufacturer Narrative
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Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Event Description
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It was reported that "the doctor found tube blocked when using on patient.Then changed new one, no impact on patient." at the time of this report, the customer has not returned our requests for additional information.The complaint file will be updated if further information is received.
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Event Description
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It was reported that "the doctor found tube blocked when using on patient.Then changed new one, no impact on patient." at the time of this report, the customer has not returned our requests for additional information.The complaint file will be updated if further information is received.
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Manufacturer Narrative
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(b)(4).The reported complaint of the catheter being blocked could not be confirmed based on the sample received.The customer returned one snaplock assembly.No epidural catheter was returned.The returned sample was visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.A functional flow test was performed on the returned snaplock assembly.A lab inventory epidural catheter was inserted from the proximal end into the returned snaplock assembly until it bottomed out and the snaplock assembly was closed.The components were confirmed to be secured by tugging gently.The snaplock assembly was connected to the lab leak tester and the pressure was increased to 10 psi to establish flow.Water could be seen immediately exiting the distal end of the catheter.The flow rate was measured at 9.2ml/min, per stopwatch, which was within the specification of 1ml/min minimum.No blockages were found.A device history record review was performed on the epidural catheter with no relevant findings.The root cause of this complaint could not be determined based upon the information provided and the sample received.No further action was required at this time.Teleflex will continue to monitor and trend for reports of this nature.
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Search Alerts/Recalls
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