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

Catalog Number	10800175
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2025
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 alaris pca administration kit leaked.The following information was provided by the initial reporter: patient called in the nurse to their room to advise her ¿iv was leaking.¿ nurse noticed that on the pca tubing, the round white piece was leaking.
Additional Manufacturer Narrative
One sample was received for quality investigation.The sample received was of a primary infusion set and does not match the reported product number of 10800175.The customer was contacted regarding the differences, but they stated that the sample that was submitted was the sample they were given by the staff member that reported the issue.Based on the fact that the sample does not match the reported complaint, and the reported issue could not be identified from the sample submitted, the customer complaint of leakage was not verified.Priming of the sample was also conducted to see if the infusion set submitted showed signs of leakage.There was no sign of leakage.Due to the product reported not being received, an investigation could not be performed, and a root cause could not be determined.A device history record review could not be performed because the lot number is unknown.

• Brand Name: BD ALARIS PCA ADMINISTRATION KIT
• 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: 22157846
• Report Number: 9616066-2025-01502
• Device Sequence Number: 15276957
• Product Code: FPA
• UDI-Device Identifier: 10885403234408
• UDI-Public: (01)10885403234408
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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: 10800175
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 08/18/2025
• 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