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

Catalog Number	11448964
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris secondary set tubing that is connected to the drip chamber came apart.The following information was provided by the initial reporter: event: "i was taking patients tafasitamab-cxix down from the iv pool into the chemo bag since patient's treatment was done.As i was placing it into the chemotherapy bag to discard; the tubing that is connected to the drip chamber came apart.I showed rn in the room with me at the time and informed my nurse manager *** rn.I finished discarding the chemo and proceeded to wash my arms from elbow down just in case since i only had gloves on.".
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4)- follow up mdr for device evaluation.Multiple photos were received with the customer's complaint of separation.The issue was immediately verified with the photos showing the tubing detached from drip chamber.This failure has been observed in the past and even though the sample is not available for testing, the root cause can be identified as improper application of solvent during assembly.The manufacturer was notified of this instance.There have been corrective actions applied to the production of this set since occurrence of this failure to ensure proper set assembly.A device history record review for model 11448964 lot number 23059010 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2023.There were no quality notifications issued for the failure mode reported by the customer during the 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.H3 other text : see h10 manufacture narrative.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17607380
• Report Number: 9616066-2023-01782
• Device Sequence Number: 6161893
• Product Code: FPA
• UDI-Device Identifier: 10885403234743
• UDI-Public: (01)10885403234743
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/22/2024

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 Expiration Date: 05/02/2026
• Device Catalogue Number: 11448964
• Device Lot Number: 23059010
• 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: 08/04/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown