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

Catalog Number 491452

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2023

Event Type  malfunction  

Event Description

Report 1 of 8 it was reported that while using vial surepath collection kit 500, there was a cracked vial containing patient sample.No patient impact reported.The following information was provided by the initial reporter: "cracked caps on vials - i attach evidence of 8 vials that arrived with broken caps, before having been processed by the multiprocessor instruments.8 vials from lot 2300761.Are each of the 8 vials samples from different patients? yes was there any impact on patient samples for diagnostic testing? yes did the patients' samples have to be taken again? yes if patients were re-sampled, were there any changes or delays in treatment? we are waiting for them to come to take the new sample.".

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).H3: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H6.Investigation summary: the customer complaint is for vials with broken caps for material: 491452, lot number: 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: 300761.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 the lot number.

Event Description

Report 1 of 8.It was reported that while using vial surepath collection kit 500, there was a cracked vial containing patient sample.No patient impact reported.The following information was provided by the initial reporter: "cracked caps on vials: i attach evidence of 8 vials that arrived with broken caps, before having been processed by the multiprocessor instruments.8 vials from lot: 2300761.Are each of the 8 vials samples from different patients? yes.Was there any impact on patient samples for diagnostic testing? yes.Did the patients' samples have to be taken again? yes.If patients were re-sampled, were there any changes or delays in treatment? we are waiting for them to come to take the new sample.".

• 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: 17909764
• MDR Text Key: 325351390
• Report Number: 3008007472-2023-00028
• 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

• Date FDA Received: 10/10/2023
• 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
• Date Manufacturer Received: 11/16/2023
• 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