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

Catalog Number	11610341
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris smartsite secondary set separated.The following information was received by the initial reporter with the verbatim: secondary tubing fell apart when trying to spike chemotherapy bag.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint that the secondary tubing fell apart could not be verified due to the product not being returned for failure investigation.Device history record review for model 11610341 lot number 22119220 was performed.The search showed no matches for the model and lot in our internal system.Dhr unable to be performed.The root cause of this failure could not be identified without a failure investigation.
Event or Problem Description
No additional information was provided.Material #: 11610341, batch #: 22119220.It was reported by customer that the secondary tubing fell apart when trying to spike chemotherapy bag.Verbatim: rcc received the complaint via email.Email as attached.Secondary tubing fell apart when trying to spike chemotherapy bag.

• Brand Name: BD ALARIS SMARTSITE 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: 17794229
• Report Number: 9616066-2023-01921
• Device Sequence Number: 12304636
• Product Code: FPA
• UDI-Device Identifier: 50885403221840
• UDI-Public: (01)50885403221840
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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: 11610341
• Device Lot Number: 22119220
• 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: 09/06/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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