MAUDE Adverse Event Report: BECTON DICKINSON BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE; CAPILLARY BLOOD COLLECTION FUNNEL

Catalog Number	366616
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b.Medical device type: there were multiple medical device types reported to be involved.The information for the additional device type is as follows: jka.There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: g4.Pma / 510(k)#: k230493.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd minidraw¿ finger sleeve, extra-large there was sample leaking from an unspecified number of devices.There were no health consequences or impacts reported.
Event or Problem Description
It was reported when using the bd minidraw¿ finger sleeve, extra-large there was sample leaking from an unspecified number of devices.There were no health consequences or impacts reported.
Additional Manufacturer Narrative
Investigation summary bd had not received samples or photos for investigation.Therefore, 32 retention samples from bd inventory were evaluated by functional testing and 1380 by visual inspection.No issues were observed as all samples met specifications.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 is unable to be confirmed for the indicated failure mode sample leakage.Bd was not able to identify a root cause for the indicated failure mode.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.

• Brand Name: BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE
• Common Device Name: CAPILLARY BLOOD COLLECTION FUNNEL
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20884740
• Report Number: 2243072-2024-01209
• Device Sequence Number: 18311648
• Product Code: GIM
• UDI-Device Identifier: 50382903666169
• UDI-Public: (01)50382903666169(11)240206(17)250221(10)3233001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K230391
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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 Expiration Date: 02/21/2025
• Device Catalogue Number: 366616
• Device Lot Number: 3233001
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2024
• 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