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 10/04/2023

Event Type  malfunction  

Manufacturer Narrative

D4.Medical device expiration date: unknown 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.H4.Device manufacture date: unknown.

Event Description

It was reported that the vial surepath collection kit 500 was cracked while containing patient sample.There was no report of patient impact.The following information was provided by the initial reporter, translated from spanish: there was a rejection for the patient from the clinic due to the issue of a vial with a broken cap.Client comments that it is necessary to notify the patient that a new sample is required to perform the study.Inadequate/unsatisfactory sample quality, due to poor condition of the vial due to broken cap, new collection and/or follow-up with the treating physician is required.

Manufacturer Narrative

H.6 investigation summary the customer complaint is for a cracked vial cap from an unknown lot number of 491452.A review of the dhr and a retain analysis could not be performed because the lot number was not provided.Additionally, a returned sample nor photographs of the complaint mode were available.Therefore, the complaint could not be confirmed.Material 491452 is produced at the bd mebane, nc facility on a validated and automated manufacturing line.The capper section 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.Over torquing caps during production could cause cracked caps.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.The pm is performed by using a calibrated servo torque verifier that is compared against the application torque value.A historical review of pm's identified that there has never been a failure of the servo torque verification pm events.A 12-month complaint review for the defect mode of cracked cap was performed and identified previous complaints for the item 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 the vial surepath collection kit 500 was cracked while containing patient sample.There was no report of patient impact.The following information was provided by the initial reporter, translated from spanish: there was a rejection for the patient from the clinic due to the issue of a vial with a broken cap.Client comments that it is necessary to notify the patient that a new sample is required to perform the study.Inadequate/unsatisfactory sample quality, due to poor condition of the vial due to broken cap, new collection and/or follow-up with the treating physician is required.

• 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: 18073345
• MDR Text Key: 327401318
• Report Number: 3008007472-2023-00052
• 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: 05/07/2024

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: Other
• Device Catalogue Number: 491452
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Female