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	11/18/2024
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 the customer that tubing leaking from filter upon priming tubing.No patient harm.
Additional Manufacturer Narrative
Investigation summary: the customer reported the filter was leaking during priming and returned one used set of material 24301-0007t, lot 24085241.Upon initial visual examination, the set had no defects or abnormalities.The set was tested with a water infusion, and the complaint of leakage from filter air vent was verified.The filter was cut away from the rest of the set and forwarded to the supplier of the filter.The supplier of the filter component confirmed the failure of leakage during testing.They cut open the filter and identified the source of the leakage as an incomplete vent membrane sealing.They reviewed their process and were able to define the root cause of the incomplete sealing.The root cause is related to insufficient cleaning and replacements.They addressed this by doubling the rate of maintenance of the assembly equipment.The complaint was also communicated with manufacturing personnel to be vigilant and to escalate any issues accordingly.A device history record review was performed.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
Sample received.

• 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: 20867199
• Report Number: 9616066-2024-01911
• Device Sequence Number: 18316306
• 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): 06/20/2025

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: 24085241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/20/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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