MAUDE Adverse Event Report: BECTON DICKINSON AS LVP SS BAG 20D LOW SORB SS TEX 0.2M; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	24301-0007T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	11/18/2024
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 # 24301-0007t.Batch # 24085241.It was reported by customer that leaking from the bonded area between the end of the tubing and the texium.
Event or Problem Description
Material # 24301-0007t.Batch # 24085241.It was reported by customer that leaking from the bonded area between the end of the tubing and the texium.Verbatim: lot# 24085241-24301-0007t- reported leaking from the bonded area between the end of the tubing and the texium.Chemo exposure to patient and pregnant clinician.
Additional Manufacturer Narrative
Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.No product will be returned per customer.No investigation was performed.

• Brand Name: AS LVP SS BAG 20D LOW SORB SS TEX 0.2M
• 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: 20874940
• Report Number: 9616066-2024-01923
• Device Sequence Number: 8800956
• Product Code: FPA
• UDI-Device Identifier: 10885403223198
• UDI-Public: (01)10885403223198(11)240826(17)270826(10)24085241
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/31/2024

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: 24301-0007T
• Device Lot Number: 24085241
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 12/08/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown