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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIPATH IMAGING, INC VIAL SUREPATH COLLECTION KIT 500; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED

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TRIPATH IMAGING, INC VIAL SUREPATH COLLECTION KIT 500; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED Back to Search Results
Catalog Number 491452
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/08/2023
Event Type  malfunction  
Event Description
Report 1 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).A vial was reduced for the correct sealing of the sample and not affect the patient's result (figure 1).Lot no.3010747".
 
Manufacturer Narrative
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.
 
Event Description
Report 1 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).A vial was reduced for the correct sealing of the sample and not affect the patient's result (figure 1).Lot no.3010747".
 
Manufacturer Narrative
H.6.Investigation summary: the customer complaint is for vials with broken caps for material 491452 lot numbers 2300761.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 2300761 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 2300761.A visual retain analysis was performed on one clamshell (25 vials) from item 491452 lot 2300761.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 2300761.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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Brand Name
VIAL SUREPATH COLLECTION KIT 500
Type of Device
PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
Manufacturer (Section D)
TRIPATH IMAGING, INC
1022 corporate park drive
mebane NC 27302
Manufacturer (Section G)
TRIPATH IMAGING, INC
1022 corporate park drive
mebane NC 27302
Manufacturer Contact
jennifer suh
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17593236
MDR Text Key321634433
Report Number3008007472-2023-00024
Device Sequence Number1
Product Code MKQ
UDI-Device Identifier10382904914520
UDI-Public10382904914520
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
P970018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number491452
Device Lot Number2300761
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/08/2023
Initial Date FDA Received08/22/2023
Supplement Dates Manufacturer Received11/16/2023
Supplement Dates FDA Received11/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
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