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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
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#: 24085241.It was reported by customer that compounding a nivolumab 480 mg / 48 ml dose.After priming the tubing, they noticed hood was wet underneath the tubing and realized that the tubing was leaking at the filter.Verbatim#: rcc received a complaint via email.Email(s) attached.I was compounding a nivolumab 480 mg / 48 ml dose.After priming the tubing, i noticed my hood was wet underneath the tubing and realized that the tubing was leaking at the filter.Item# 24301-0007t; lot# (10)24085241.
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.
Event or Problem Description
Material#: 24301-0007t, batch number#: 24085241.It was reported by customer that compounding a nivolumab 480 mg / 48 ml dose.After priming the tubing, they noticed hood was wet underneath the tubing and realized that the tubing was leaking at the filter.Verbatim#: rcc received a complaint via email.Email(s) attached.I was compounding a nivolumab 480 mg / 48 ml dose.After priming the tubing, i noticed my hood was wet underneath the tubing and realized that the tubing was leaking at the filter.Item# 24301-0007t, lot# (10)24085241.

• 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: 20874941
• Report Number: 9616066-2024-01924
• Device Sequence Number: 15653633
• 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: KS
• 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): 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