MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 5ML HEPARIN 10 UNIT; HEPARIN, VASCULAR ACCESS FLUSH

Catalog Number	306414
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) follow up.It was reported the syringe is empty of any fluid, but the syringe is pulled back, capped and packaged as though there is fluid in the syringe.Our quality team has completed a device history record review for material number 306414 and lot number 429953n.The review did not identify any abnormalities during the production process that could have contributed to the defect, and all quality tests were within specification.Due to the unavailability of a sample for return, a comprehensive sample investigation could not be conducted.Should you encounter any further issues with our product, we would appreciate the opportunity to perform a detailed analysis.
Event or Problem Description
Material # 306414 batch # 429953n.It was reported by the customer that the syringe is empty of any fluid, but the syringe is pulled back, capped and packaged as though there is fluid in the syringe.Verbatim: reporting an additional event that occurred today.Noted by user at time of preparation for administration to the patient.Lot #4 29953n exp: 2026-04-30 please provide me with a contact for a manager or director for bd¿s quality assurance team.This is our 6th report of finding a syringe that is empty of any fluid, but the syringe is pulled back, capped and packaged as though there is fluid in the syringe.The fluid is clear, so the risk if this is not noticed is that air is injected into the patient instead of fluid.If this is a small infant or a child with a right to left shunt, the consequences could be catastrophic.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

• Brand Name: SYRINGE 5ML HEPARIN 10 UNIT
• Common Device Name: HEPARIN, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21968510
• Report Number: 1911916-2025-00330
• Device Sequence Number: 8691916
• Product Code: NZW
• UDI-Device Identifier: 30382903064145
• UDI-Public: (01)30382903064145(11)241106(17)260430(10)429953N
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K090680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 306414
• Device Lot Number: 429953N
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown