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

Catalog Number 491452

Device Problem Leak/Splash (1354)

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

Event Date 09/24/2023

Event Type  malfunction  

Manufacturer Narrative

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

It was reported that while using vial surepath collection kit 500, that one vial cap was cracked while containing patient sample.There was a total loss of the sample.Healthcare professional was wearing ppe.The following information was provided by the initial reporter: "broken cap hpv sample could you confirm whether this sample from the incident on (b)(6) 2023 was contaminated with the hpv virus?: no.- could you confirm if the sample was leaking due to the problem?: no.- if yes, was the healthcare professional exposed to biohazardous fluids (example: blood, tissue, patient sample, waste)?: no.- if the professional was exposed, how was he exposed?: (clothing, skin, mucous membrane or non-intact skin) not applicable.- was personal protective equipment (ppe) being used?: yes.- was any medical intervention necessary?: no.- about impact on the sample.Was there a total loss of the sample?: yes.".

Manufacturer Narrative

The following fields were updated due to correction: e1: initial reporter addr 1: (b)(6).G3: report source: foreign.H.6 investigation summary the customer complaint is for one (1) vial with a cracked cap from item 491452 lot number 2300761.Material 491452 is produced at the bd mebane, nc facility on a validated automated manufacturing line.The capper is validated to inspect for application torque and unseated or missing caps.Vials that fail to meet inspection requirements (i.E., outside of the validated application torque) are rejected automatically after the capper section.To ensure that the capper remains in validated state, a quarterly preventive maintenance (pm) is established that is used to confirm accuracy of application torque for each of the capper heads.A review of the two (2) pm events that bracketed the production date identified that the results of the verification were acceptable.A total of (b)(4) kits ( (b)(4) vials) were produced.A total of (b)(4) vials were leak tested in a vacuum chamber during in-process testing and did not identify any leaking or cracked cap defects.The review of the manufacturing dhr for the lot number identified that it was complete and accurate with no indication of abnormalities during manufacturing.The review of the bill of materials (bom) for 491452 lot 2300761 identified that raw cap material 700030951 lot numbers 2137781 and 2222109 were used during the production.A review of the incoming inspection results for 700030951 lot numbers 2137781 and 2222109 identified (b)(4) caps were inspected from each lot and passed the acceptance criteria with zero defects identified.A visual retain analysis was performed on one clamshell ( (b)(4) vials) from item 491452 lot 2300761.No cracked caps were identified during the retain analysis.A sample was not returned but a picture was provided that showed a cracked cap.The complaint is confirmed.A 12-month complaint review for the defect mode of cracked caps was performed and identified previous complaints for the item number and lot number.Bd performs regular trending to determine if a corrective and preventative action (capa) is required, and as of this time the threshold for a capa has not been reached.Bd will continue to monitor and evaluate trends.

Event Description

It was reported that while using vial surepath collection kit 500, that one vial cap was cracked while containing patient sample.There was a total loss of the sample.Healthcare professional was wearing ppe.The following information was provided by the initial reporter: "broken cap hpv sample could you confirm whether this sample from the incident on (b)(6) 2023 was contaminated with the hpv virus? no.- could you confirm if the sample was leaking due to the problem? no.- if yes, was the healthcare professional exposed to biohazardous fluids (example: blood, tissue, patient sample, waste)? no.- if the professional was exposed, how was he exposed? (clothing, skin, mucous membrane or non-intact skin) not applicable.- was personal protective equipment (ppe) being used? yes.- was any medical intervention necessary? no.- about impact on the sample.Was there a total loss of the sample? yes.".

• 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: 17982357
• MDR Text Key: 326365823
• Report Number: 3008007472-2023-00035
• Device Sequence Number: 1
• Product Code: MKQ
• UDI-Device Identifier: 10382904914520
• UDI-Public: (01)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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2024

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: Health Professional
• 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: 09/25/2023
• Initial Date FDA Received: 10/22/2023
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/24/2024
• 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