MAUDE Adverse Event Report: TRIPATH IMAGING, INC VIAL SUREPATH COLLECTION KIT 500; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Model Number 491452

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2023

Event Type  malfunction  

Event Description

It was reported that the barcode label was incorrect for vial surepath collection kit 500.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese: the number read by the two dimensional bar code and the number printed on the label were different.The vial was used for the first time, and when its bar code was read, a duplicate error was displayed.(as originally reported) from these situations, the two dimensional bar code was suspected to be wrong.

Manufacturer Narrative

D4.Medical device expiration date: unknown.E1.Initial reporter facility name: (b)(6) medical center medical association hospital.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.

Manufacturer Narrative

H.6 investigation summary: material 491452 is produced at the bd mebane, (b)(6) facility on an automated manufacturing line referred to as the shibuya vial filling line.The customer complained the bd auto staining equipment displaying a duplicate barcode error from an unknown lot of 491452, although it was the first time the barcode had been read.The customer stated that the number read from the 2d barcode was different than the human readable number and suspects the 2d barcode to be incorrect.A review of the dhr and retain analysis could not be performed because a lot number was not provided.A review of the dhr could not be performed because no lot number was provided.However, the certificate of analysis received with each lot number of vial labels contains a statement that confirms no duplicate barcode numbers are present.A return sample was not provided; nor was a picture provided, and therefore the complaint was not able to be confirmed.A complaint review by lot number could not be performed because no lot number was provided.A review of previous complaints for duplicate barcode labels on material 491452 was performed and identified no previous complaints.

Event Description

It was reported that the barcode label was incorrect for vial surepath collection kit 500.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese: * the number read by the two dimensional bar code and the number printed on the label were different.* the vial was used for the first time, and when its bar code was read, a duplicate error was displayed.(as originally reported) from these situations, the two dimensional bar code was suspected to be wrong.(additional information entered by (b)(6) on 6/23/2023).The affected product had already been discarded at the facility, and the lot number and the photo are not available.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17222179
• MDR Text Key: 318077241
• Report Number: 3008007472-2023-00006
• Device Sequence Number: 1
• Product Code: MKQ
• UDI-Device Identifier: 10382904914520
• UDI-Public: 10382904914520
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/09/2023

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 Model Number: 491452
• 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: 06/09/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 08/09/2023
• Supplement Dates FDA Received: 08/14/2023
• 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