MAUDE Adverse Event Report: BECTON DICKINSON BD MICROTAINER® CONTACT-ACTIVATED LANCET; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number	366593
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is htl.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.H3.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
It was reported while using bd microtainer® contact-activated lancets, the first lancet used did not give sufficient blood flow so a second lancet was used.The patient reported finger pain and staff noticed some skin on the lancet but did not observe any other abnormalities.Later on, the patient had a red and swollen finger.They found a piece of the lancet blade inside the incision.The patient removed the piece of the blade themselves.No medical intervention was necessary.No further impact was reported.
Additional Manufacturer Narrative
Bd had not received samples or photos for investigation.Therefore, retention samples from bd inventory were evaluated by functional testing, each used to puncture a test pad, and no issues were observed relating to insufficient blood flow or blade breaks off as all samples met specifications.A review of the device history record indicated a quality notification was raised for activation issues.However, lot passed all in-process and final quality checks for lot release.This complaint is unable to be confirmed for the indicated failure modes insufficient blood flow or blade breaks off.Bd was not able to identify a root cause for the indicated failure modes.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.
Event or Problem Description
It was reported while using bd microtainer® contact-activated lancets, the first lancet used did not give sufficient blood flow so a second lancet was used.The patient reported finger pain and staff noticed some skin on the lancet but did not observe any other abnormalities.Later on, the patient had a red and swollen finger.They found a piece of the lancet blade inside the incision.The patient removed the piece of the blade themselves.No medical intervention was necessary.No further impact was reported.

• Brand Name: BD MICROTAINER® CONTACT-ACTIVATED LANCET
• Common Device Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19353969
• Report Number: 2243072-2024-00637
• Device Sequence Number: 7466103
• Product Code: FMK
• UDI-Device Identifier: 30382903665939
• UDI-Public: (01)30382903665939
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

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
• Operator of Device: Other
• Device Catalogue Number: 366593
• Device Lot Number: C4P11L8
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2023
• 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