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

Catalog Number	MP5313-C
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxplus pressure rated extension set had connection issues.The following information was provided by the initial reporter: the threaded connection is loose which has caused leaking to occur.Described that staff is now tightening the blue connector on the line before using it on a pt.This seemed to resolve the issue.Pt/clinician harm: no, just exposure to blood.
Additional Manufacturer Narrative
H3: if a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of separation other component - leak could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model mp5313-c lot number 25059098 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD MAXPLUS PRESSURE RATED EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22925933
• Report Number: 9616066-2025-02593
• Device Sequence Number: 18432394
• Product Code: FPA
• UDI-Device Identifier: 10885403236716
• UDI-Public: (01)10885403236716(10)25059098
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/27/2025

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: MP5313-C
• Device Lot Number: 25059098
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown