MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE; BLOOD GAS SYRINGE IVD, LITHIUM HEPARIN

Catalog Number	364316
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.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
Patient 1 of 3: it was reported when using bd preset¿ arterial blood collection syringe, there was inadequate blood volume in an unspecified number of devices.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following fields were updated due to additional information: e.1.Initial reporter city: (b)(6).E.1.Initial reporter facility name: (b)(6).Investigation summary: bd received 2 photos for investigation.Evaluation of the two photos did not indicate evidence of air bubbles.The samples shown are not compatible to be used with each other.No retained samples were inspected, as no lot number was provided.The device history records could not be reviewed as the lot number is unknown.This complaint has not been confirmed for the indicated failure mode: air bubbles.No definitive root cause could be established for the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for the identification of emerging trends.
Event or Problem Description
Patient 1 of 3, it was reported when using bd preset¿ arterial blood collection syringe, there was inadequate blood volume in an unspecified number of devices.No adverse impact was reported regarding the patient or user.

• Brand Name: BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE
• Common Device Name: BLOOD GAS SYRINGE IVD, LITHIUM HEPARIN
• Manufacturer (Section D): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 23838599
• Report Number: 9617032-2025-02260
• Device Sequence Number: 18600802
• Product Code: JKA
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2026

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 Catalogue Number: 364316
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 02/10/2026; Not provided
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 03/10/2026; 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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