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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris smartsite gravity blood set separated the following information was received by the initial reporter with the following: the blood tubing that i showed you today here at mission providence, has the bag spike ends that are detached from the tubing.This was discovered in our pacu department.They claim this was the third package that had this issue; however, they don't have the lot number from the first 2 packages.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
The customer reported the spikes at end of tubing were separating, and returned a photo and sample of material 10010903, lot 24059427.The set was examined, and the complaint was verified.The sample was separated at the blood tubing in both of the 2 spikes.The tubings had signs of insufficient solvent when examined under a microscope.The manufacturing site found the root cause of the separation at spike to be related to solvent assembly process.The failure mode was addressed under a work order on (b)(6) 2024 to fix the issues found within the solvent dispenser.Device history record review for model 10010903 lot number 24059427 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2024.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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional information was provided.

• 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: 20202146
• Report Number: 9616066-2024-01302
• Device Sequence Number: 7535398
• Product Code: FPA
• UDI-Device Identifier: 07613203020879
• UDI-Public: (01)07613203020879
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/24/2024

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: 24059427
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown