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

Model Number	MFS102
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxguard¿ flow controller administration set with needleless y-site(s)with the dial open, unable to prime; also after priming, unable to infuse at the prescribed rate or open.The following information was provided by the initial reporter: are you continuing to have issues with mfs102? yes.Has anyone else reported issues? the problem appears to be widespread (i.E.Not specific to a particular lot, etc¿).The errors include priming; with the dial open, unable to prime; also after priming, unable to infuse at the prescribed rate or open.Thus far we have seen at least a dozen incidences of various reported issues.Conseuqently, this has resulted in wasting medications and decrease in patient satisfaction.I could be available tomorrow at 10am or anytime after 2pm.If these times don¿t work, we could look into next week as well.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated, due to additional information: d10: device available for eval? yes, d10: returned to manufacturer on: 14-jun-2023.H6: investigation summary: three samples (model #mfs102) were returned by the customer.It was reported, by the customer ,that priming with the dial open, unable to prime.Also after priming, unable to infuse at the prescribed rate or open.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were attached to an iv bag filled with water and attempted to be primed.One set was able to be primed, and was able to flow at all rates.The failure was unable to be replicated in this sample.Two sets were unable to be primed, and unable to flow at any rates.The male luer, y-site and flow controller were cut from the sets.Flow was restored in each of the sets, once the flow controller was cut from the line.No excess solvent was observed, at the ports of the flow controller.The customer complaint can be verified in these sets.A device history record review could not be performed on model mfs102, because a lot number is unknown.The root cause is caused, by a misplaced gasket.
Event or Problem Description
It was reported, that the bd maxguard¿ flow controller administration set with needleless y-site(s).With the dial open, unable to prime.Also after priming, unable to infuse at the prescribed rate or open.The following information was provided by the initial reporter: are you continuing to have issues with mfs102? yes.Has anyone else reported issues? the problem appears to be widespread (i.E.Not specific to a particular lot, etc.).The errors include priming with the dial open, unable to prime.Also after priming, unable to infuse at the prescribed rate or open.Thus, far we have seen at least a dozen incidences of various reported issues.Consequently, this has resulted in wasting medications and decrease in patient satisfaction.I could be available tomorrow at 10am or anytime after 2pm.If these times don¿t work, we could look into next week as well.

• Brand Name: BD MAXGUARD¿ FLOW CONTROLLER ADMINISTRATION 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: 17014741
• Report Number: 9616066-2023-01025
• Device Sequence Number: 20551180
• Product Code: FPA
• UDI-Device Identifier: 10885403236334
• UDI-Public: (01)10885403236334
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/10/2023

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: MFS102
• Device Catalogue Number: MFS102
• Device Lot Number: UNKNOWN
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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