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

Catalog Number	366616
Medical Device Problem Codes	Leak/Splash (1354); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter addr 1: (b)(6).D2b: additional medical device type: gim.G5: additional pma / 510(k)#: k230391.The manufacturing location for this product is rmr.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.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 that when using one (1) bd minidraw¿ finger sleeve, extra-large, there is blood smearing.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following fields were updated due to additional information: describe event or problem: b.5 it was reported that when using bd minidraw¿ finger sleeve, extra-large, there is was blood pooling in 2 devices and blood leakage in 1 device.Additionally one device was reported to be difficult to connect a collection tube to the device connector.No adverse impact was reported regarding the patient or user.H.6 imdrf annex a grid: a1208 - fitting problem (2183).
Event or Problem Description
It was reported that when using bd minidraw¿ finger sleeve, extra-large, there is was blood pooling in 2 devices and blood leakage in 1 device.Additionally one device was reported to be difficult to connect a collection tube to the device connector.No adverse impact was reported regarding the patient or user.

• Brand Name: BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• 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: 21526415
• Report Number: 2243072-2025-00206
• Device Sequence Number: 9696398
• Product Code: JKA
• 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: K230493
• 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): 10/02/2025

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: 02/07/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 10/17/2025
• 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