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 02/10/2024

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter first name: (b)(6).H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during use with the vial surepath collection kit 500, a vial containing patient sample had a cracked cap.There was no report of impact to patient or user.Report 2 of 2.

Event Description

It was reported that during use with the vial surepath collection kit 500, a vial containing patient sample had a cracked cap.There was no report of impact to patient or user.Report 2 of 2.

Manufacturer Narrative

H.6 investigation summary.The customer complaint is for cracked vial cap from item (b)(4) lot number 3026730.A 12-month complaint review for the defect mode of cracked cap was performed and identified previous complaints for the item number but no previous complaints for the lot number.Complaints are trended at the mebane, nc facility and trigger levels have not been met.Therefore, no capa initiation determination (cid) or corrective or preventative action (capa) has been initiated for the issue.Bd quality will continue to monitor and trend events related to this issue to determine if corrective actions are required.Material 491452 is produced at the bd mebane, nc facility on an automated vial filling manufacturing line.The capper section of the vial filling line contains capper heads, which caps the vials to a validated application torque controlled by servo motor.The capper is validated to inspect for application torque.Vials that fail to meet inspection requirements (i.E., outside of the validated application torque) are rejected automatically after the capper section.Production of material 491452 lot 3026730 started on 02feb2023 at the bd mebane, nc production facility.A total of (b)(4) vials were leak tested in a vacuum chamber during in-process testing and identified 0 defects for leaks or cracked caps.The review of the manufacturing device history record for the lot number identified that it was complete and accurate with no indication of abnormal activities during manufacturing.The review of the bill of materials (bom) for 491452 lot 3026730 identified that two raw cap lot numbers were used during production: material 700030951 lot numbers 2298932 and 2284513.Raw cap item number (b)(4) is inspected as part of incoming inspection.Review of the incoming inspection results for 700030951 lot numbers 2298932 and 2284513 identified 800 caps were inspected and passed the acceptance criteria.A visual retain analysis was performed on one clamshell (25 vials) from item (b)(4) lot 3026730.The complaint mode was not identified during retain analysis.A returned sample was not available.However, pictures and videos were provided that show the cracked cap.Therefore, the complaint is confirmed.

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18839465
• MDR Text Key: 337030997
• Report Number: 3008007472-2024-00005
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2024

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: Other
• Device Catalogue Number: 491452
• Device Lot Number: 3026730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• 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