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

Catalog Number	366616
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the bd minidraw¿ finger sleeve, extra-large, blood was pooling in the finger sleeve of two (2) units.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary bd received had not received samples or photos in support of the investigation.Retention samples from bd inventory were evaluated by both visual examination and functional testing, and no issues were observed relating to blood pooling.The device was manufactured according to product 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 blood pooling.Bd was able to trace the root cause for the indicated failure mode to user technique.As part of bd's ongoing process to track and trend complaint data, an update to the minidraw eifu was initiated to address the residual blood in finger sleeves that may occur.The new verbiage in the warning section will state: "practice universal precautions in accordance with your facility¿s procedures.Use gloves, gowns, eye protection, other personal protective equipment, and engineering controls to protect from residual blood on finger and/or finger sleeve, blood splatter, blood leakage, and potential exposure to blood-borne pathogens." additionally, the new text in step 8 of the blood collection procedure will state: "residual blood may be present on patient's finger and/or finger sleeve.".
Event or Problem Description
Report 1 of 2: it was reported that when using the bd minidraw¿ finger sleeve, extra-large, blood was pooling in the finger sleeve of 1 device.No adverse impact was reported regarding the patient or user.
Event or Problem Description
Report 1 of 2: it was reported that when using the bd minidraw¿ finger sleeve, extra-large, blood was pooling in the finger sleeve of 1 device.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following fields were updated due to additional information: b.5 describe event or problem: report 1 of 2: it was reported that when using the bd minidraw¿ finger sleeve, extra-large, blood was pooling in the finger sleeve of 1 device.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: 21559008
• Report Number: 2243072-2025-00234
• Device Sequence Number: 9261636
• Product Code: JKA
• UDI-Device Identifier: 50382903666169
• UDI-Public: (01)50382903666169(11)241112(17)260228(10)4257001
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 10/29/2025

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: 02/28/2026
• Device Catalogue Number: 366616
• Device Lot Number: 4257001
• 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: 02/09/2025
• Supplement Date Received by Manufacturer: 10/02/2025; 10/29/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 10/06/2025; 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2024
• 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