TRIPATH IMAGING, INC VIAL SUREPATH COLLECTION KIT 500; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
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Catalog Number 491452 |
Device Problems
Break (1069); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/08/2023 |
Event Type
malfunction
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Event Description
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Report 2 of 3.It was reported that while using vial surepath collection kit 500, there was a cracked cap of a vial containing a patient sample.No patient impact reported.The following information was provided by the initial reporter: "vial caps crack.The client reports: currently there are two new incidents in the guadalajara area where they report 3 damaged roads.2 vials were reduced to be able to carry out a correct sealing of the sample and not affect the patients with their results.Lot no.3010747, 2300761 (figures 1 and 2).".
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Manufacturer Narrative
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E.1.Initial reporter addr 1: (b)(6).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Manufacturer Narrative
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H.6.Investigation summary: the customer complaint is for vials with broken caps for material 491452 lot number 3010747.The investigation consisted of a review of the device history records from production, retain analysis, customer return analysis and related customer complaint trending.The review of the manufacturing batch records for material 491452 lot 3010747 identified that it was complete and accurate with no indication of any issues or abnormal activities during the production of the lot.There were zero defects observed during the inspection of the caps used in the production of material 491452 lot 3010747.A visual retain analysis was performed on one clamshell (25 vials) from material 491452 lot 3010747.The complaint mode was not identified during retain analysis.A returned sample was not available so no formal inspection could be performed.However, pictures were provided that show the cracked cap.Therefore, the complaint is confirmed.A 12-month complaint review for the defect mode of cracked cap and empty vial was performed and identified previous complaints for the item number but no previous complaints for lot 3010747.Bd performs regular trending and as of this time the threshold for a corrective and preventative action (capa) has not been reached.Bd will continue to monitor and evaluate trends.
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Event Description
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Report 2 of 3.It was reported that while using vial surepath collection kit 500, there was a cracked cap of a vial containing a patient sample.No patient impact reported.The following information was provided by the initial reporter: "vial caps crack.The client reports: currently there are two new incidents in the guadalajara area where they report 3 damaged roads.2 vials were reduced to be able to carry out a correct sealing of the sample and not affect the patients with their results.Lot no.3010747, 2300761 (figures 1 and 2).".
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Search Alerts/Recalls
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