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

Catalog Number	491452
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Report 11 of 26 it was reported when the bd surepath¿ collection vial arrived at the lab for testing, the vial lid was cracked.The sample will need to be recollected.There were no health impact or consequences reported.
Additional Manufacturer Narrative
E.1 initial reporter address: (b)(6).A device evaluation is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: the customer complaint is for cracked vial caps from item: 491452, lot number: 3319283 and 3317494.A 12-month complaint review for the defect mode of cracked cap was performed and identified previous complaints for the item number and one of the lot numbers.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.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 vial filling line cap application torque value.Production of material: 491452, lots: 3319283 and 3317494 started on 15nov2023 and 16nov2023.A review of the two (2) pm events that bracketed the production date identified that the results of the verification were acceptable.Further review identified that there has never been a failure of the servo torque verification pm events.A total of 800 vials were leak tested in a vacuum chamber during in-process testing of the lot and identified 0 defects for leaks and cracked caps.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: 3319283 and 3317494 identified that two raw cap lot numbers were used during production: material: 700030951, lot numbers: 3233884 and 3255601.Raw cap item number: 700030951 is inspected during incoming inspection.A review of the incoming inspection results for 700030951, lots: 3233884 and 3255601 identified a sampling of caps were inspected and passed the acceptance criteria.A visual retain analysis was performed on one clamshell (25 vials) from item: 491452, lots: 3319283 and 3317494.The complaint mode was not identified during retain analysis.No samples were returned to the bd mebane location, but pictures were provided.The pictures show caps with cracks on the cap around the outer thread ring.The complaint is confirmed.
Event or Problem Description
Report 11 of 26.It was reported when the bd surepath¿ collection vial arrived at the lab for testing, the vial lid was cracked.The sample will need to be recollected.There were no health impact or consequences reported.

• Brand Name: BD SUREPATH¿ COLLECTION VIAL
• Common Device Name: 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20921611
• Report Number: 3008007472-2024-00045
• Device Sequence Number: 5118672
• Product Code: MKQ
• UDI-Device Identifier: 10382904914520
• UDI-Public: (01)10382904914520(11)231115(17)261029(10)3319283
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P970018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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
• Operator of Device: Other
• Device Catalogue Number: 491452
• Device Lot Number: 3319283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2024
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown