MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS PCA SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10800175
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
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 bd alaris pca was damaged.The following information was received by the initial reporter with the following verbatim: it was reported by the customer that setting up a pca and when priming the initial tubing, morphine dripping out of the machine.3 staff members witnessed pca tubing leaking at the top of tubing near the area where it is screwed into the morphine syringe.Approximately 1ml was dripped onto the floor.Prior to priming the second tubing, 3 staff verified that the morphine syringe had 29ml left in it.1ml was documented on the flowsheet under morphine waste volume at 1815 and after discussing with pharmacist and charge nurse, 1ml was wasted in the pyxis.2ml was the prime volume which is from the second tubing and documented on the flowsheet under morphine prime volume.
Additional Manufacturer Narrative
Investigation summary: the customer reported that the set was leaking, and returned one sample of material 10800175, lot 24045438.Upon initial visual examination, the set had no defects or abnormalities.When the set was infused with water, the water immediately sprayed out of the inlet port, the purple female luer.On closer inspection, there was a small cut in the tubing where it connects to the luer.A device history record review was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing site address the issue through a quality alert, which communicated on october 29th, 2024 the correct use of the expander during assembly process.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD ALARIS PCA SET
• 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: 24598409
• Report Number: 9616066-2026-00651
• Device Sequence Number: 8568528
• Product Code: FPA
• UDI-Device Identifier: 10885403234408
• UDI-Public: (01)10885403234408(17)270423(10)24045438
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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): 04/03/2026

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: 10800175
• Device Lot Number: 24045438
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown