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

Catalog Number	37262E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set tubing snapped off at the chamber.This occurred once each in an unspecified lot and lot 22119067.The following information was provided by the initial reporter: "icv tubing snapped off at chamber".
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: unknown.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.D.4.Medical device lot #: 22119067.D.4.Medical device expiration date: 04-nov-2025.H.4.Device manufacture date: 03-nov-2022.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary 3 samples were received and tested by our quality team.The sets were separated upon receipt and the customer's complaint has been verified.Visual analyses using a high powered digital microscope was performed and the separated portion of tubing lacked solvent (or glue) that was supposed to be applied during production.This is the root cause of the failure- improper application of solvent during set assembly.The manufacturer has been notified and is actively taking steps and corrective actions to eliminate this type of failure from reoccurring.A device history record review for model 42103e-07 lot number 22089353 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set tubing snapped off at the chamber.This occurred once each in an unspecified lot and lot 22119067.The following information was provided by the initial reporter: "icv tubing snapped off at chamber".

• Brand Name: BD ALARIS¿ SMARTSITE¿ EXTENSION 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16842317
• Report Number: 9616066-2023-00785
• Device Sequence Number: 6823559
• Product Code: FPA
• UDI-Device Identifier: 10885403235276
• UDI-Public: 10885403235276
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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: 37262E
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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