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

Catalog Number	366614
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd minidraw¿ finger sleeve, medium there was blood pooling.There were no health consequences or impacts reported.
Additional Manufacturer Narrative
The manufacturing location for this product is roechling medical rochester (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.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: k230391 d4.Medical device expiration date: not applicable.Product does not expire.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields have been updated with additional/corrected information: d.9.Device available for eval: yes d.9.Returned to manufacturer on: 21-jun-2024 d.4.Medical device expiration date: 30-apr-2023 investigation summary: bd received 10 expired samples for investigation.Nevertheless, the samples were evaluated by visual examination for factors related to the indicated failure mode of blood pooling with the incident lot.The issue was not observed as all product specifications were met.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 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.
Event or Problem Description
It was reported when using the bd minidraw¿ finger sleeve, medium there was blood pooling.There were no health consequences or impacts reported.

• Brand Name: BD MINIDRAW¿ FINGER SLEEVE, MEDIUM
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19636754
• Report Number: 2243072-2024-00763
• Device Sequence Number: 8793502
• Product Code: GIM
• UDI-Device Identifier: 50382903666145
• UDI-Public: (01)50382903666145
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 10/03/2024

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 Expiration Date: 04/30/2023
• Device Catalogue Number: 366614
• Device Lot Number: 1328001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2022
• 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