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

Catalog Number	10013361T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Material #: 10013361t.Batch#: unknown.It was reported by customer that we had another issue with a leak but this time from a different site on the line with an oxaliplatin at zuckerberg.Can somebody please come in this week to assess, we need to understand why we are experiencing these leaks suddenly.Verbatim: complaint received via email(s) attached.We had another issue with a leak but this time from a different site on the line with an oxaliplatin at zuckerberg.Can somebody please come in this week to assess, we need to understand why we are experiencing these leaks suddenly.
Event or Problem Description
Material #: 10013361t batch#: unknown it was reported by customer that we had another issue with a leak but this time from a different site on the line with an oxaliplatin at zuckerberg.Can somebody please come in this week to assess, we need to understand why we are experiencing these leaks suddenly.Verbatim: complaint received via email(s) attached.We had another issue with a leak but this time from a different site on the line with an oxaliplatin at zuckerberg.Can somebody please come in this week to assess, we need to understand why we are experiencing these leaks suddenly.
Additional Manufacturer Narrative
It was reported that there was a leak.One sample model 10013361t 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.Even though the issue was not able to be replicated actions have been initiated to investigate this failure mode.A device history record review could not be performed because a lot number was not provided by the customer.

• Brand Name: AS LVP SS BAG 20D 2SS TEX 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: 20825280
• Report Number: 9616066-2024-01784
• Device Sequence Number: 8843341
• Product Code: FPA
• UDI-Device Identifier: 10885403223204
• UDI-Public: (01)10885403223204
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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: 10013361T
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 02/06/2025
• 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