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	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Mat#: mx9175 batch#: 20096317it was reported that bd maxguard extension set with standard needless connector would not prime.It was reported by initial reporter that: the extension tubing they had sometimes won¿t prime.They¿ve tried taking the end cap off the tubing and still won¿t prime.Verbatim: blockage issue (could not prime): are you able to provide the date of event in format dd-mmm-yyyy? (b)(6) 2023.How many defective set(s) affected in this incident? unknown.Was issue being described noted before, or during used? during use.Was there any patient involvement? tubing had to be replaced during care.Any adverse events or serious injury reported to patient or healthcare professional? no.What was the patient outcome? anticipated outcome.Was there any delay of, or change in, the course of treatment due to this event? delay in care.What procedure was being performed? cardiac cath lab prep.Fluids were being hung in the prep area.What medication was used in the procedure? normal saline.Was there any medical intervention due to this event? no.
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
Mat#: mx9175 batch#: 20096317it was reported that bd maxguard extension set with standard needless connector would not prime.It was reported by initial reporter that: the extension tubing they had sometimes won¿t prime.They¿ve tried taking the end cap off the tubing and still won¿t prime.Verbatim: blockage issue (could not prime): - are you able to provide the date of event in format dd-mmm-yyyy? 07/24/2023 - how many defective set(s) affected in this incident? unknown - was issue being described noted before, or during used? during use - was there any patient involvement? tubing had to be replaced during care - any adverse events or serious injury reported to patient or healthcare professional? no - what was the patient outcome? anticipated outcome - was there any delay of, or change in, the course of treatment due to this event? delay in care - what procedure was being performed? cardiac cath lab prep.Fluids were being hung in the prep area.- what medication was used in the procedure? normal saline - was there any medical intervention due to this event? no.
Additional Manufacturer Narrative
Investigation summary: two unused samples model mx9175 (one sample lot 23019031 and one sample lot 22099394) was returned for investigation.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The set was attached to a 10 ml bd syringe filled with water.The set was able to be flushed.The customer complaint that the set was unable to be flushed was unable to be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model mx9175 lot number 20096317 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 21sep2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model mx9175 lot number 23019031 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 06jan2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model mx9175 lot number 22099394 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 21sep2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 17511144
• Report Number: 9616066-2023-01715
• Device Sequence Number: 18124866
• 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): 08/21/2023

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: 09/19/2025
• Device Catalogue Number: MX9175
• Device Lot Number: 20096317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2020
• 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