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

Catalog Number	MP5302-C
Medical Device Problem Codes	Leak/Splash (1354); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.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 needleless connector was loose the following information was received by the initial reporter with the following verbatim: verbatim: blows offs of extensions in ct and while bolussing fluids.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
The customer reported ext sets are blowing off, and returned one sample of material mp5302-c, lot unknown.Upon initial visual examination, the set had no defects or abnormalities.The set was manipulated and tested with water for leaks, no issues were found.The complaint could not be replicated.The inferred issue that the customer is seeing may be related to a condition with the new male luer design that was confirmed during testing.The new male luer design is able to be pushed past the collar threads and all the back onto the tubing, as part of the new design.This condition does not exhibit a failure mode.A device history record review could not be performed on material mp5302-c because the lot number is unknown.The root cause of this failure could not be identified without a replicated failure.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 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: 20218087
• Report Number: 9616066-2024-01304
• Device Sequence Number: 12731851
• Product Code: FPA
• UDI-Device Identifier: 10885403230134
• UDI-Public: (01)10885403230134
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/09/2024

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: MP5302-C
• Device Lot Number: UNKNOWN
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown