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	Insufficient Information (4580)
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 number#: unknown.It was reported by customer that had a paclitaxel spill from the tubing connecting to the filter.It exposes 2 pregnant nurses who were caring for the patient.This is truly disheartening.The staff has lost faith in the security of your system.
Additional Manufacturer Narrative
One sample model 24301-0007t, lot 24055599 was returned for investigation by the customer.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed with water and an extension set was attached to the texium luer.The set was pressurized at 30 psi for 10 minutes.No leak was observed.The customer complaint was unable to be replicated.Although we could not confirm the reported failure, a trend has been identified, and actions have been initiated to investigate the issue.Corrective actions taken during this investigation will be implemented in our production process to further increase the robustness and reliability of the device and prevent future occurrences of this type.A device history record review for model 24301-0007t lot number 24055599 was performed.The search showed that a total of (b)(4)units in 1 lot number was built on 27may2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
No additional information.

• 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: 20866684
• Report Number: 9616066-2024-01910
• Device Sequence Number: 18350629
• Product Code: FPA
• UDI-Device Identifier: 10885403223198
• UDI-Public: (01)10885403223198(11)240527(17)270527(10)24055599
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: 24301-0007T
• Device Lot Number: 24055599
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown