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

Catalog Number	10010903
Medical Device Problem Codes	Defective Component (2292); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2025
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
T was reported that bd alaris smartsite gravity blood set kinked.The following information was received by the initial reporter with the following verbatim.It was reported by customer that the tubing itself gets occluded from the roller clamps.This is enough to stop / severely limit flow through the tubing.If it occurs, we can manually pinch the tubing to try to open it back up.The iv set isn't dripping, because the portion of kinked tubing is behind the roller clamp.Iv tubing (on the blood sets and on the syringe pumps) seems softer and more prone to kinking than what we previously used.
Additional Manufacturer Narrative
Four photos were submitted for quality evaluation.Three photos were of the product and one photo was a picture of the product label.Visual examination of the product indicates that the tubing was kinked.Further examination of the of tubing indicate ridges on the kink of the tubing.The origin of the ridges are a result of clamping the tubing with the roller clamp.The kinking caused by the roller clamp in not permanent and will return to its original shape by itself or if the tubing is massaged.The customer complaint of kinked tubing is confirmed.A physical sample was not received and therefore any flow issues that could be cause by kinking could not be verified.The investigation was forwarded to manufacturing for possible root cause analysis.After investigation, the possible root cause of the kinked tube could be related to the activation of the roller clamp during assembly/quality testing and improper placement of the component inside the bag by the assembler.No corrective actions have been put in place at the manufacturing location that manufactured the sample provided because the product will no longer be produced at that location.A quality alert was created to communicate the issue and reinforce the correct assembly instructions, ensuring that the roller clamp is not activated during the assembly process or quality tests.A device history record review for model 10010903 lot number 24129114 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD ALARIS SMARTSITE GRAVITY BLOOD 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: 21962300
• Report Number: 9616066-2025-01114
• Device Sequence Number: 9188947
• Product Code: FPA
• UDI-Device Identifier: 07613203020879
• UDI-Public: (01)07613203020879(11)241206(17)271206(10)24129114
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K050115
• 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): 08/11/2025

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: 10010903
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown