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

Catalog Number	10016242
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
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 secondary set was damaged the following information was received by the initial reporter with the following: it was reported by the customer that ongoing issue with our secondary blood tubing where the tubing is defective because the filter is upside down and it cannot be used.
Additional Manufacturer Narrative
One sample model 10016242, lot 25029347 was returned for investigation.The set was examined for defects and abnormalities.The filter was inverted.No other defects or abnormalities were observed.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturer's investigation, the possible root cause of the incorrect assembly issue (inverted blood drip chamber) could be related to opportunities in the assembly method.The standard work instruction is currently being modified to include a new guidance fixture.A device history record review for material# 10016242 and lot# 24099390 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 13sep2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
Physical sample was returned.
Event or Problem Description
No additional information provided.
Additional Manufacturer Narrative
No product was returned by the customer and the provided photo does not show the sample or confirm reported issues.The customer complaint of misassembly could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 10016242 because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD ALARIS SECONDARY 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: 22309224
• Report Number: 9616066-2025-01649
• Device Sequence Number: 7997374
• Product Code: FPA
• UDI-Device Identifier: 07613203017398
• UDI-Public: (01)07613203017398(11)241120(17)271120(10)24119324
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K882302
• 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,Followup
• Report Date (Section B): 10/07/2025

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: 10016242
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 07/03/2025; 10/07/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/11/2025; 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown