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

Model Number	22003E-07
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris smartsite extension set was clogged.The following information was provided by the initial reporter: it has been brought to our attention by nursing that they are having trouble with the item not functioning/flushing properly.
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.
Additional Manufacturer Narrative
H.6.Investigation: 13 samples model 20159e were returned for investigation.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The set was attached to a cut off bd syringe to see if a fluid path can be observed while the piston is in the activated position.A fluid path was observed while the piston was in the activated position for 11 of the 13 samples.The smartsites were then connected to a 10 ml bd syringe filled with blue dye water and the sets were attempted to be flushed.11 of the 13 sets were successfully flushed.The customer complaint that the product us not functioning/ flushing properly was replicated.The root cause is unknown.A device history record review for model 22003e - 07 lot number 21119800 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A trend for this occlusion issue has been identified for this product line.Capa # 1998036 has been initiated, and a team has been assembled in order to investigate the issue.
Event or Problem Description
It was reported that the bd alaris smartsite extension set was clogged.The following information was provided by the initial reporter: it has been brought to our attention by nursing that they are having trouble with the item not functioning/flushing properly.

• 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: 14346773
• Report Number: 9616066-2022-00566
• Device Sequence Number: 12046359
• Product Code: FPA
• UDI-Device Identifier: 50885403242043
• UDI-Public: 50885403242043
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 06/03/2022

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: Health Professional
• Device Expiration Date: 11/02/2022
• Device Model Number: 22003E-07
• Device Catalogue Number: 22003E-07
• Device Lot Number: 21119800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2021
• 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