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

Catalog Number	2420-0500
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
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#: 24083005.It was reported by the customer that on midazolam infusion, the primary line below the spike, just above the closed vent, was leaking out large amounts of the medication.Lost approx 50-60 ml within minutes.No harm.
Event or Problem Description
Material#: 2420-0500 , batch#: 24083005.It was reported by the customer that on midazolam infusion, the primary line below the spike, just above the closed vent, was leaking out large amounts of the medication.Lost approx 50-60 ml within minutes.Rcc received a complaint via email.On midazolam infusion, the primary line below the spike, just above the closed vent, was leaking out large amounts of the medication.Lost approx 50-60 ml within minutes.Manufacturer code/model: 2420-0500 serial or lot number: (b)(6).
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of leakage could not be verified due to the product not being returned for failure investigation.A device history record review for material# 2420-0500 and lot# 24083005 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 01aug2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• 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: 20894587
• Report Number: 9616066-2024-02010
• Device Sequence Number: 7716099
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: (01)07613203012430(11)240801(17)270801(10)24083005
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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: 24083005
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown