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

Catalog Number	MP5314-C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd maxplus pressure rated extension set with removable needleless connector was damaged the following information was received by the initial reporter with the following verbatim: rcc received a complaint via email.Email(s) attached.Nurses are saying that the ll connector piece that turns to attach to the iv is very hard to turn this results in sometimes not getting it attached properly.They think it is but then it leaks and they have a bloody mess to deal with, even worse the patient sees it and gets worried.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
The customer reported luer lock issues, and returned 2 samples mp5314-c, lot 24019372.Upon initial visual examination, the sets had no defects or abnormalities.The sets were tested at 10 psi for 30 seconds to test if the connection was airtight, and the sets passed.There were no issues found with the luer lock connections.No other issues were found with the sets.The root cause could not be traced to the manufacturing process, and the root cause is officially unknown.There is a possibility the root cause for the luer lock issues is clinical practice related, and the clinical team was notified.Device history record review for model mp5314-c lot number 24019372 was performed.The search showed that a total of 43,203 units in 1 lot number was built on 31jan2024.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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• Brand Name: BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19507019
• Report Number: 9616066-2024-00862
• Device Sequence Number: 11614141
• Product Code: FPA
• UDI-Device Identifier: 10885403236723
• UDI-Public: (01)10885403236723
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K083472
• Number of Events Summarized: 1
• Summary Report (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): 08/06/2024

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 Catalogue Number: MP5314-C
• Device Lot Number: 24019372
• 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: 05/14/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown