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

Catalog Number	MP5314-C
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the bd maxplus pressure rated extension set had a loose component.The following information was provided by the initial reporter: a routine iv insertion was completed on this patient at 2125 using the 'bd maxplus pressure rated extension set with removable clear needleless connector' to connect to the int.I paid extra attention to tightening the connector to the int because the rad tech was at bedside waiting to take the patient for a ct scan with contrast.It is common for these extension sets to come loose during contrast administration in ct scan.Tech called me after performing her test injection for the ct scan with the auto injector because the patient was bleeding significantly from his iv.I found the screwing portion of this extension set completely loose and the extension set was out of the int hub allowing the patient to free bleed.I reapplied the extension set and screwed it as tightly as possible, cleaned up the patient, and reapplied a secure dressing.When returning to my department i received another call from radiology that the int is leaking again with the autoinjector test flush.I changed this extension set out with a new one and we were able to continue with patient care.
Additional Manufacturer Narrative
One sample and one photo was received for product mp5314-c, lot 25055270.The product was primed and connected to a sample bd infusion set.A simulated infusion was conducted in order to determine if the mp5314-c would spontaneously separate from the connector or show signs of leakage.There were no issues with the infusion set.The customer complaint of loose component - leakage was not verified.A root cause analysis was not conducted because the failure was not replicated.A device history record review for model mp5314-c lot number 25055270 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.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23337168
• Report Number: 9616066-2025-03207
• Device Sequence Number: 13147701
• Product Code: FPA
• UDI-Device Identifier: 10885403236723
• UDI-Public: (01)10885403236723(17)280512(10)25055270
• 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): 01/29/2026

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: 25055270
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown