MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXGUARD EXTENSION SET WITH STANDARD NEEDLESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX9175
Medical Device Problem Code	Failure to Prime (1492)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 that maxguard extension set with standard needless connector that tubing was not priming.The following information was provided by initial reporter and the verbatim: "my cardiac cath lab team has escalated a second time their concern with the tubing below not priming.The product is mx9175, lot # 23019031.She said that during cases this weekend the functionality was hit or miss.When they couldn¿t get the tubing to prime they just kept hooking up a new set until they found one that would prime.This is a huge waste and delays patient care.".
Event or Problem Description
It was reported that maxguard extension set with standard needless connector that tubing was not priming.The following information was provided by initial reporter and the verbatim: "my cardiac cath lab team has escalated a second time their concern with the tubing below not priming.The product is mx9175, lot # 23019031.She said that during cases this weekend the functionality was hit or miss.When they couldn¿t get the tubing to prime they just kept hooking up a new set until they found one that would prime.This is a huge waste and delays patient care.".
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.The customer complaint that the tubing is not priming could not be verified due to the product not being returned for failure investigation.A device history record review for model mx9175 lot number 23019031 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• Brand Name: BD MAXGUARD EXTENSION SET WITH STANDARD NEEDLESS CONNECTOR
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17484119
• Report Number: 9616066-2023-01692
• Device Sequence Number: 7366792
• Product Code: FPA
• UDI-Device Identifier: 10885403237676
• UDI-Public: (01)10885403237676
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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: 01/06/2026
• Device Catalogue Number: MX9175
• Device Lot Number: 23019031
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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