MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS 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	06/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.A sample is available for evaluation.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 would not flush.The following information was provided by the initial reporter: the extension set would not flush.
Additional Manufacturer Narrative
H6: investigation summary.Four samples (model #20028e) and a primary set were returned by the customer.It was reported that they cannot flush through the extension set.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.Each extension set was connected to the returned primary set, and attempted to be primed with saline.Saline would not prime passed the filter.Each extension set was attempted to be flushed with a 10 ml bd syringe filled with saline.Each set was unable to be flushed.The customer complaint can be verified.A quality notification has been sent to the supplier, and the samples have been sent for further investigation.During the supplier investigation, the functionality of the filter was found to be according to the supplier specification.However, excess solvent was found at the connection of the filter and the tubing.A quality notification was sent to the manufacturer.The manufacturer investigation confirmed the excess solvent.The main root cause was determined to be attributed to double gumming (repeating the solvent application operation twice).As a preventative action a quality notification was created for this defect.A device history record review for model 20028e lot number 21119585 was performed.The search showed that a total of 17,603 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.
Event or Problem Description
It was reported that the bd alaris smartsite extension set would not flush.The following information was provided by the initial reporter: the extension set would not flush.

• 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: 14881064
• Report Number: 9616066-2022-00796
• Device Sequence Number: 12332879
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 11/07/2022
• 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