MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MPX5300-C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
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 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 during flush with bd maxplus¿ pressure rated extension set with needleless connector and y-site leakage occurred.Small delay in patient care.2nd of 2 reports.The following information was provided by the initial reporter: i am writing to report three instances of incidents related to iv flushes.Two of these incidents occurred when a nurse was flushing a patient iv, and the third incident took place in radiology where the iv was flushed, but a leakage was noticed by the radiology technician.Fortunately, these incidents did not have any negative impact on the patient's outcome, and the only requirement was the replacement of the iv extension.A patient safety report has been submitted to address the possibility of iv-related injuries.The delay in patient care was minimal, and staff members have been informed to carefully check iv extensions to ensure they are not defective.
Event or Problem Description
It was reported that during flush with bd maxplus¿ pressure rated extension set with needleless connector and y-site leakage occurred.Small delay in patient care.2nd of 2 reports.The following information was provided by the initial reporter: i am writing to report three instances of incidents related to iv flushes.Two of these incidents occurred when a nurse was flushing a patient iv, and the third incident took place in radiology where the iv was flushed, but a leakage was noticed by the radiology technician.Fortunately, these incidents did not have any negative impact on the patient's outcome, and the only requirement was the replacement of the iv extension.A patient safety report has been submitted to address the possibility of iv-related injuries.The delay in patient care was minimal, and staff members have been informed to carefully check iv extensions to ensure they are not defective.
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.The customer complaint of leakage from the set could not be verified due to the product not being returned for failure investigation.Device history record review for model mpx5300-c lot number 23029208 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.H3 other text : see h10.

• Brand Name: BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE
• 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: 17367742
• Report Number: 9616066-2023-01500
• Device Sequence Number: 15017366
• Product Code: FPA
• UDI-Device Identifier: 10885403237218
• UDI-Public: 10885403237218
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083472
• 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): 08/10/2023

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 Expiration Date: 02/11/2026
• Device Catalogue Number: MPX5300-C
• Device Lot Number: 23029208
• 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: 06/27/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• 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