MAUDE Adverse Event Report: TRIPATH IMAGING, INC. BD MICROTAINER® CONTACT-ACTIVATED LANCET; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number	366592
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
Report 1 of 2.It was reported that while using bd microtainer® contact-activated lancet, the cap was damaged of one lancet.No patient impact reported.The following information was provided by the initial reporter: "the customer reported that the cap was damaged and the needle (blade) did not come out.Date of event occurance : (b)(6) 2023, cap damaged: 1product (lot no.B9m29a1).".
Event or Problem Description
Report 1 of 2.It was reported that while using bd microtainer® contact-activated lancet, the cap was damaged of one lancet.No patient impact reported.The following information was provided by the initial reporter: "the customer reported that the cap was damaged and the needle (blade) did not come out.Date of event occurence : 03/03/2023, cap damaged: 1 product (lot no.B9m29a1).".
Additional Manufacturer Narrative
H.6.Investigation summary: bd received 3 samples for investigation.Two samples from lot b9d39l1 and one sample from lot b9m29a1.All three samples were missing their tab cap.One of the samples from lot b9d39l1 was already activated and had its protective cap removed.The other two samples were evaluated by functional testing, each used to puncture a test pad, and the indicated failure mode for unable to activate with the incident lot was not observed.Additionally, retention samples of each reported lot number from bd inventory were evaluated by functional testing, each having their tab caps removed and puncturing a test pad, and upon completion the indicated failure mode for loose tab cap was observed.The failure mode of unable to activate was not observed as all lancets punctured.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode loose tab cap.This complaint could not be confirmed for unable to activate.Bd has initiated further root cause investigation relating to the issue of loose tab cap through corrective and preventive actions.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends." the following fields were updated due to additional information: d9: device available for evaluation:  yes.D9: returned to manufacturer on: 06-sept-2023.

• Brand Name: BD MICROTAINER® CONTACT-ACTIVATED LANCET
• Common Device Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): TRIPATH IMAGING, INC.; 4025 stirrup creek drive; suite no. 400; durham NC 27703
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17658875
• Report Number: 3004173866-2023-00001
• Device Sequence Number: 20409742
• Product Code: FMK
• UDI-Device Identifier: 50382903665926
• UDI-Public: 50382903665926
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K223243
• 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): 09/20/2023

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: 12/31/2025
• Device Catalogue Number: 366592
• Device Lot Number: B9M29A1
• 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: 08/25/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• 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