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 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date of event is unknown.The date received by manufacturer has been used for this field.E.1 initial reporter addr 1: (b)(6).H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

Patient 11 of 16.It was reported that while using the vial surepath collection kit 500 that the sure path collection vial containing patient sample cracked.16 patients were affected.The following information was provided by the initial reporter while processing, all the vials corresponding to lot 3060223 broke.They came from the clinic.Broken caps of sample vials.- could you confirm the affected number of vials with broken caps? 16.

Manufacturer Narrative

H.6.Investigation summary: the customer complaint is for sixteen (16) vials with broken caps (post sample collection) from item 491452 lot number 3060223.Material 491452 is produced at the bd mebane, nc facility on a validated automated manufacturing line referred to as the shibuya vial filling line.The capper section of the shibuya vial filling line contains eight (8) capper heads, which caps the vials to a validated application torque controlled by servo motor.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 eight (8) heads.The pm is performed by using a calibrated servo torque verifier that is compared against the shibuya cap application torque value.Production of material 491452 lot 3060223 started on 07mar2023.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 432 kits (216,000 vials) were produced and were inspection using ansi general level ii, single sampling, normal, at an aql of 0.65%.A total of 800 vials were qc inspected prior to product disposition with a total of 0 defects observed.An additional 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 abnormal activities during manufacturing.The review of the bill of materials (bom) for 491452 lot 3060223 identified that raw cap lot number material 700030951 lot number 3017888 was used during the production.Raw cap item number 700030951 is inspected using ansi general level ii, single sampling, normal, at an aql of 0.65%.A review of the incoming inspection results for 700030951 lot number 3017888 identified 800 caps were inspected from each lot and passed the acceptance criteria with zero defects identified.A sample was not returned to the mebane, nc facility for evaluation.Although pictures were provided, the pictures did not contain any vials with the complaint defect.A visual retain analysis was performed on one clamshell (25 vials) from item 491452 lot 3060223.No cracked/broken caps were identified during the retain analysis.The complaint is not confirmed.

Event Description

Patient 11 of 16.It was reported that while using the vial surepath collection kit 500 that the sure path collection vial containing patient sample cracked.16 patients were affected.The following information was provided by the initial reporter while processing, all the vials corresponding to lot 3060223 broke.They came from the clinic.Broken caps of sample vials.- could you confirm the affected number of vials with broken caps? 16.

• 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 ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18004578
• MDR Text Key: 326508747
• Report Number: 3008007472-2023-00037
• 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: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 491452
• Device Lot Number: 3060223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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