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

Catalog Number	MX9060
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the bd maxguard extension set with needleless y-site(s) experienced liquid flow though while connected.The following information was provided by the initial reporter: product is not letting liquid flow though while connected but does allow liquid flow when not connected.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported by the customer that the bd maxguard extension set with needleless y-site(s) experienced liquid flow though while connected.The following information was provided by the initial reporter: product is not letting liquid flow though while connected but does allow liquid flow when not connected.
Additional Manufacturer Narrative
H6: investigation summary: 312 samples (model #mx9060) were returned by the customer.It was reported by the customer that the product is not letting liquid flow though while connected, but does allow liquid flow when not connected.Evaluations of 59 samples were performed.The sample size quantity was determined per 1701-008-000 swi sample size selection work instruction v.08 (dir 10000123008_08).The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were connected to a bd primary set and attempted to be primed.Of the 59 samples tested, there were 7 sets unable to be primed, and fluid was unable to flow.The customer complaint can be verified in these samples.The failed samples were attempted to be flushed at the top connector and then at the y-site on the set using a bd 10 ml syringe.The sets were able to be flushed at both locations.The sets were connected to the bd primary set a second time.This time the sets were able to be primed, and fluid was able to flow.The sets were examined under magnification where a small amount of excess solvent can be observed at the connection of the bottom of the y-site and the tubing.The force of the flushing of the set was most likely able to remove the occlusion.A quality notification was sent to manufacturing.The manufacturer was able to verify the complaint.A mapping of the process for mx9060 to determine the root cause.The possible causal factors were determined to be that there was no solvent dispenser verification and an incorrect level of solvent being applied to the set.A quality alert will be generated to notify and reinforce the line clearance process and correct verification of solvent.A device history record review for model mx9060 lot number 22089364 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD MAXGUARD 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 ; 8015296192
• MDR Report Key: 15794891
• Report Number: 9616066-2022-01724
• Device Sequence Number: 14621392
• Product Code: FPA
• UDI-Device Identifier: 10885403237591
• UDI-Public: 10885403237591
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/13/2023

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 Expiration Date: 08/17/2025
• Device Catalogue Number: MX9060
• Device Lot Number: 22089364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• 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