MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S); INTRAVASCULAR ADMINISTRATION SET

Model Number	MFS141
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that during use with bd maxguard flow controller extension set with needleless y-site(s) the device was clogged.This is the 1st of 3 occurrences.The following information was provided by the initial reporter: defective product (x3) with the same lot number.Tried to flush the tubing but didn't work.
Event or Problem Description
It was reported that during use with bd maxguard flow controller extension set with needleless y-site(s) the device was clogged.This is the 1st of 3 occurrences.The following information was provided by the initial reporter: defective product (x3) with the same lot number.Tried to flush the tubing but didn't work.
Additional Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer.It was reported by customer that "defective product (x3) with the same lot number and they tried to flush the tubing but didn't work." could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model # mfs141 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• Brand Name: BD MAXGUARD FLOW CONTROLLER EXTENSION SET WITH NEEDLELESS Y-SITE(S)
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16464102
• Report Number: 9616066-2023-00285
• Device Sequence Number: 20476110
• Product Code: FPA
• UDI-Device Identifier: 10885403236471
• UDI-Public: (01)10885403236471
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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: Other
• Device Model Number: MFS141
• Device Catalogue Number: MFS141
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown