MAUDE Adverse Event Report: BECTON DICKINSON AS LVP 20D DEHP 2SS CV; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2420-0500
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Material: 2420-0500, batch#: unknown.It was reported by the customer that the alarm was sounding as an occlusion so when the rn got to the bedside, they opened the pump to find the bubble in the tubing inside.No injury to patient.
Additional Manufacturer Narrative
It was reported that the tubing ballooned.One photo was taken by the customer that verifies the complaint.The probable root cause for the failure is determined to be a user issue.If the infusion set is not loaded correctly, a ballooning in the pumping segment tubing is possible.The clinical team has been made aware of the issue and can provide additional instructional material for proper loading of the alaris pumps.A device history record review could not be performed because a lot number was not provided by the customer.
Event or Problem Description
Material: 2420-0500.Batch#: unknown.It was reported by the customer that the alarm was sounding as an occlusion so when the rn got to the bedside, they opened the pump to find the bubble in the tubing inside.Alaris primary tubing 20gtt cat# 2420-0500 -the alarm was sounding as an occlusion so when the rn got to the bedside, they opened the pump to find the bubble in the tubing inside.

• Brand Name: AS LVP 20D DEHP 2SS CV
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20892698
• Report Number: 9616066-2024-01996
• Device Sequence Number: 21093148
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: (01)07613203012430
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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 Catalogue Number: 2420-0500
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/22/2025
• 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