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

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.

• 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 Key: 17593236
• MDR Text Key: 321634433
• Report Number: 3008007472-2023-00024
• Device Sequence Number: 1
• Product Code: MKQ
• UDI-Device Identifier: 10382904914520
• UDI-Public: 10382904914520
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P970018
• Number of Events Reported: 1
• 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 Number: 491452
• Device Lot Number: 2300761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 11/16/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female