MAUDE Adverse Event Report: BECTON DICKINSON BD ALARIS EXTENSION SET W/ ANTISIPHON VALVE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	30862-0500
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris extension set w/ antisiphon valve had incorrect label content.The following information was provided by the initial reporter: for #30862-0500 the online label says a pv of.6 and the label the customer received say pv 1ml.Could you advise the reason for the difference.
Additional Manufacturer Narrative
B.3.The date of event is unknown; bd awareness date used.E.1.Address was not located, and (b)(6) was used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Two photos taken verify the customer complaint that the prime volumes were different.R&d confirmed that 1 ml is the correct prime volume.We are working internally to update the website to show the correct prime volume.A device history record review could not be performed because a lot number was not provided by the customer.

• Brand Name: BD ALARIS EXTENSION SET W/ ANTISIPHON VALVE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23713013
• Report Number: 2243072-2025-01439
• Device Sequence Number: 8910353
• Product Code: FPA
• UDI-Device Identifier: 10885403235221
• UDI-Public: (01)10885403235221
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (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): 02/03/2026

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: 30862-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown