MAUDE Adverse Event Report: TRIPATH IMAGING, INC BD CYTOLOGY STAIN KIT; STAINS, DYE SOLUTION

Catalog Number	491458
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Eit was reported that while using bd cytology stain kit, there is missing label information on one pack.No patient impact reported.The following information was provided by the initial reporter:(b)(6) no mentioned on the pack of cytology stain kit, cat# 491458 is (b)(6) 2023.Whereas the expiry date mentioned on the hematoxylin stain 0.75: with lot# 3038847 and ea/og combo stain: with lot# 3038858 is 31-01-2024.".
Additional Manufacturer Narrative
(b)(6).A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 3008007472-2023-00034 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore, this is not considered to be a reportable malfunction.
Event or Problem Description
Eit was reported that while using bd cytology stain kit, there is missing label information on one pack.No patient impact reported.The following information was provided by the initial reporter: "xpiry no mentioned on the pack of cytology stain kit, cat# (b)(4) is 31-08-2023.Whereas the expiry date mentioned on the hematoxylin stain 0.75: with lot# 3038847 and ea/og combo stain: with lot# 3038858 is 31-01-2024.".

• Brand Name: BD CYTOLOGY STAIN KIT
• Common Device Name: STAINS, DYE SOLUTION
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17928076
• Report Number: 3008007472-2023-00034
• Device Sequence Number: 20420681
• Product Code: LEE
• UDI-Device Identifier: 00382904914585
• UDI-Public: 00382904914585
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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
• Operator of Device: Other
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 491458
• Device Lot Number: 3074390
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• 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