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

Catalog Number	366615
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is rochling medical rochester.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.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 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 when using the bd minidraw¿ finger sleeve, large there was residual blood in six devices.There were no health consequences or impacts reported.
Event or Problem Description
Report 1 of 5.It was reported when using the bd minidraw¿ finger sleeve, large there was residual blood in two devices.There were no health consequences or impacts reported.
Additional Manufacturer Narrative
The following fields were updated due to additional information: b.5 describe event or problem: report 1 of 5.It was reported when using the bd minidraw¿ finger sleeve, large there was residual blood in two devices.There were no health consequences or impacts reported.
Event or Problem Description
Report 1 of 5: it was reported when using the bd minidraw¿ finger sleeve, large there was residual blood in two devices.There were no health consequences or impacts reported.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 25-mar-2025.Investigation summary: bd received 40 samples for investigation.The samples were not evaluated as the customer stated they concluded that the issue of blood pooling is not related to the product being defective, but rather collection techniques including finger alignment and finger sizing.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.".

• Brand Name: BD MINIDRAW¿ FINGER SLEEVE, 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: 21723989
• Report Number: 2243072-2025-00395
• Device Sequence Number: 18495279
• Product Code: GIM
• UDI-Device Identifier: 50382903666152
• UDI-Public: (01)50382903666152(11)241112(17)260228(10)4247001
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Company Representative
• 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: 366615
• Device Lot Number: 4247001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 10/02/2025; 10/29/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 10/06/2025; 10/30/2025
• 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