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

Catalog Number	20159E
Medical Device Problem Codes	Complete Blockage (1094); Obstruction of Flow (2423); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 the bd alaris¿ smartsite¿ extension set had a large air bubble in the tubing.Additionally, the line was difficult to prime due to blockage, accumulating blood in the tubing.The following information was provided by the initial reporter: "a large air bubble stays in the tubing.  also to prime it you need to push extremely hard on the blue valve inside the tubing and disconnect and reconnect to the other side to fully fill the tubing, this increases contamination potential. the second issue is it accumulates blood in the tubing and cause a long blood clot.  i do not feel comfortable flushing the tubing with the blood inside.".
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.A device history record review for model 20159e lot number 22039080 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 07mar2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure was not identified as no product was returned.Even though no sample/photo was received and failure could not be confirmed, a capa (corrective action preventative action) has been initiated to investigate the customer¿s reported failure mode.
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set had a large air bubble in the tubing.Additionally, the line was difficult to prime due to blockage, accumulating blood in the tubing.The following information was provided by the initial reporter: "a large air bubble stays in the tubing.  also to prime it you need to push extremely hard on the blue valve inside the tubing and disconnect and reconnect to the other side to fully fill the tubing, this increases contamination potential. the second issue is it accumulates blood in the tubing and cause a long blood clot.  i do not feel comfortable flushing the tubing with the blood inside.".

• 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 ; 8015296192
• MDR Report Key: 15442625
• Report Number: 9616066-2022-01370
• Device Sequence Number: 12158211
• Product Code: FPA
• UDI-Device Identifier: 07613203012270
• UDI-Public: 07613203012270
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 10/19/2022

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: 03/04/2025
• Device Catalogue Number: 20159E
• Device Lot Number: 22039080
• 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: 08/23/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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