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	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
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 bd alaris pca administration kit broke.The following information was received by the initial reporter with the following verbatim bd pca tubing ref 10800175- they could not remove the white cap.When they tired again the tip of the white cap broke off into the pca tubing.
Additional Manufacturer Narrative
One sample model 10800175, lot 24045435 was returned for investigation by the customer.The set was examined for defects and abnormalities.Part of the white cap was broken off in the female luer.No defects or abnormalities were observed.The customer complaint was verified and quality notification was sent to the manufacturer.From the manufacturer's investigation, the root cause was that production personnel added solvent to the incorrect side of the female luer due fixture to prevent these conditions was not used by the production personnel.

• 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: 21735543
• Report Number: 9616066-2025-00690
• Device Sequence Number: 8798020
• Product Code: FPA
• UDI-Device Identifier: 10885403234408
• UDI-Public: (01)10885403234408(11)240423(17)270423(10)24045435
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/12/2025

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: 24045435
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/12/2025
• 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