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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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).
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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.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).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 was received disassembled.No other defects or anomalies were observed.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.Therefore, based on this, 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.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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Search Alerts/Recalls
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