Catalog Number 004200 |
Device Problem
Expiration Date Error (2528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/19/2023 |
Event Type
malfunction
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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.Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that during incoming inspection, it was "found that the printing of the expiration date was abnormal.The expiration date was incorrectly written as '2028-10-04', not '2026-10-04'".No patient involvement.
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Event Description
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It was reported that during incoming inspection, it was "found that the printing of the expiration date was abnormal.The expiration date was incorrectly written as '2028-10-04', not '2026-10-04'".No patient involvement.
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Manufacturer Narrative
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(b)(4).The reported complaint of "labeling issue - difficult to read" was confirmed based upon the sample received.The customer provided one photo and returned one unit of 004200 horizon ti lg 6/cart 120/box for investigation.The returned unit was an unopened sample in original packaging.The expiration date was incorrectly written as "2028-10-04", rather than "2026-10-04".Dhr investigation did not show issues related to complaint.Actions to address this issue, such as qualifying an improved vision system, were established by the manufacturing site under teleflex quality system.The returned sample was manufactured prior to the implementation of corrective actions.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.
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Search Alerts/Recalls
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