MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS SMARTSITE W/MANIFOLD GRAVITY & EXT SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	42511E
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
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
It was reported while using bd alaris smartsite w/manifold gravity & ext set the tubing was clogged.There was no report of patient impact.The following information was provided by the initial reporter: customer reported the tubing does not prime due to valve being placed on backwards.There was no patient harm regarding the tubing mentioned in the report.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 07-aug-2023.H6: investigation summary: a complaint of priming issues due to a check valve being assembled incorrectly was received from the customer.A device history record review for model 42511e lot number 23039320 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for this defect could not be determined.
Event or Problem Description
It was reported while using bd alaris smartsite w/manifold gravity & ext set the tubing was clogged.There was no report of patient impact.The following information was provided by the initial reporter: customer reported the tubing does not prime due to valve being placed on backwards.There was no patient harm regarding the tubing mentioned in the report.

• Brand Name: BD ALARIS SMARTSITE W/MANIFOLD GRAVITY & EXT 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: 17466767
• Report Number: 9616066-2023-01649
• Device Sequence Number: 6983021
• Product Code: FPA
• UDI-Device Identifier: 50885403235410
• UDI-Public: (01)50885403235410
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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): 08/14/2023

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 Expiration Date: 03/30/2026
• Device Catalogue Number: 42511E
• Device Lot Number: 23039320
• 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: 07/17/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2023
• 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