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

Model Number	20028E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 2 bd smartsite¿ extension sets were clogged.The following information was provided by the initial reporter: cannot flush through extension set.
Event or Problem Description
It was reported that 2 bd smartsite¿ extension sets were clogged.The following information was provided by the initial reporter: cannot flush through extension set.
Additional Manufacturer Narrative
Investigation summary: the customer reported the tubing is not flowing and returned two samples of 20028e.The 0.2 micron filter not working per customer.Filter was primed with water, and was occluded.In trying to the break the occlusion, the filter ruptured and cracked down the middle, through the vents.The second filter did not rupture, but was in fact occluded, the complaint is verified.The sample was sent to supplier to investigate the occlusion.They found no issue with the filter, and reported back that they found evidence of excess glue from the tubing at the outlet of the filter, which filled the filter outlet and caused the occlusion.Manufacturing issued a quality alert for the issue, and found the root cause to be double gumming (repeating the solvent application operation) in operation 3.Device history record review for model 20028e lot number 21119585 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 30nov2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD 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: 15235201
• Report Number: 9616066-2022-01171
• Device Sequence Number: 20447217
• Product Code: FPA
• UDI-Device Identifier: 07613203012393
• UDI-Public: 07613203012393
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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: 11/25/2024
• Device Model Number: 20028E
• Device Catalogue Number: 20028E
• Device Lot Number: 21119585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2021
• 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