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	04/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material #306414, batch # 434180n.It was reported by the customer that the syringe lacked heparin/fluid.Verbatim: rcc received a complaint via email.Email(s) attached.Sharing two additional events of air in syringe and lack of heparin/fluid.These were not saved for return.Asking for additional investigation into the manufacturing defect.The closure letters i received for the prior events state no issues with the production process but this is an increasing safety trend for this product.Event date: 4/18/2025.Ref 306414.Lot 434180n.Exp 2026-06-30.Event date: 4/19/2025.Ref 306414.Lot 43410n.Exp 2026-06-30.
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.
Additional Manufacturer Narrative
(b)(6) follow up.It was reported the syringe had air in it and lacked heparin fluid.Our quality team has completed a device history record review for material number 306414 and lot number 434180n.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.

• 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: 21994747
• Report Number: 1911916-2025-00335
• Device Sequence Number: 8312400
• Product Code: NZW
• UDI-Device Identifier: 30382903064145
• UDI-Public: (01)30382903064145(11)250103(17)260630(10)434180N
• 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: 06/30/2026
• Device Catalogue Number: 306414
• Device Lot Number: 434180N
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown