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

Catalog Number	30843E
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
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 ss cv was damaged.The following information was provided by the initial reporter: we had a nurse manager report that when connecting/priming a pca ext set (ref: 30843e) to the primary tubing they noticed a crack in the extension set tubing at the connection site of the extension set and the iv tubing.I¿m uncertain if this was from tightening the tubing too tight or if it was like that when they pulled it out of the packaging.Additional information received from the customer: any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No can you please provide an exact date of event in format dd-mmm-yyyy? (b)(6) 2025 can you please provide the lot number associated with reported issue? (10)25085756.
Additional Manufacturer Narrative
It was reported by the customer that they noticed a crack in the extension set tubing at the connection site of the extension set and the iv tubing.One sample was received for quality evaluation.Inspection of the infusion set indicates that the female luer adapter was cracked.The customer complaint of component damage was confirmed.The investigation was forwarded to the supplier group for root cause analysis.Review of the production batch was conducted and there were no anomalies recorded.The product is controlled dimensionally 2 times per production shift.The mold is regularly maintained and all maintenances have been done and recorded.There were no events that can have generated weakness of the parts were recorded during this lot production, additionally, the raw material lot used to manufacture this lot was checked and resulted to be in compliance.Based on all the information collected during the investigation, it was determined that the most probable root cause of the crack is that the connector came into contact with some chemical, such as alcohol or an antiseptic cleaner, that made the component brittle after the manufacturing process, and therefore the root cause was not due to the production of the component or manufacturing of extension set assembly.A device history record review for model 30843e lot number 25085756 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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 was provided.

• Brand Name: ALARIS
• 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: 23421207
• Report Number: 9616066-2025-03318
• Device Sequence Number: 8281047
• Product Code: FPA
• UDI-Device Identifier: 10885403235214
• UDI-Public: (01)10885403235214
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• 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): 03/30/2026

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: 30843E
• Device Lot Number: 25085756
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown