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 10/18/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter address: (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.

Event Description

It was reported that during use with the vial surepath collection kit 500, a vial containing patient sample had a cracked cap.The sample has to be recollected.

Manufacturer Narrative

The following fields have been updated with additional information: b5: it was reported that during use with the vial surepath collection kit 500, a vial containing patient sample had a cracked cap.The sample has to be recollected.H.6.Investigation summary: the customer complaint is for one (1) vial with a cracked cap from item 491452 lot number 2229702.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 800 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 2229702 identified that raw cap material 700030951 lot number 2152139 was used during the production.A review of the incoming inspection results for 700030951 lot number 2152139 identified 800 caps were inspected from the lot and passed the acceptance criteria with zero defects identified.A visual retain analysis was performed on one clamshell (25 vials) from item 491452 lot 2229702.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 but not the 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.H3 other text: see h.10.

• 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: 18615954
• MDR Text Key: 334223480
• Report Number: 3008007472-2024-00003
• 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,Followup
• Report Date: 05/08/2024

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: 2229702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 01/31/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• 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