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

Catalog Number	22003E-07
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
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 5 of the bd iv extension set alaris® smartsite were unable to flush.The following information was provided by the initial reporter: unable to flush extension tubings with 10 ml 0.9% normal saline pre-filled syringes.The lot numbers of 2 extension tubing's that flushed were different than the 5-extension tubing with the same lot numbers (22039352), that did not flush.This has happened with 1 or 2 extensions tubing here and there.
Event or Problem Description
It was reported that 5 of the bd iv extension set alaris® smartsite were unable to flush.The following information was provided by the initial reporter: unable to flush extension tubings with 10 ml 0.9% normal saline pre-filled syringes.The lot numbers of 2 extension tubing's that flushed were different than the 5-extension tubing with the same lot numbers (22039352), that did not flush.This has happened with 1 or 2 extensions tubing here and there.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 11-jan-2023.H6: investigation summary four samples (model #22003e-07) were returned by the customer.It was reported by the customer that the extension tubing would not flush.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The samples were connected to a cut off syringe tip to check that the fluid path is in an activated position/open when connected to a syringe.The samples were then attempted to be flushed with water using a 10ml bd syringe to confirm an open fluid path.The fluid paths of 2 of the samples were open and those samples were able to be flushed.The failure was unable to be replicated in these samples.The fluid paths of the 2 other samples were not open and were unable to be flushed.The customer complaint can be verified in these samples.A root cause was unable to be determined.Due to an increase in incidents of this failure mode, a trend for this occlusion issue has been identified for this product line, a capa (corrective action preventative action) has been initiated, and a team has been assembled in order to investigate the issue.A device history record review for model 22003e-07 lot number 22039352 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h10.

• Brand Name: BD IV EXTENSION SET ALARIS® SMARTSITE
• 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: 16126701
• Report Number: 9616066-2022-02168
• Device Sequence Number: 19630326
• Product Code: FPA
• UDI-Device Identifier: 10885403242045
• UDI-Public: 10885403242045
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/03/2023

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: 03/28/2023
• Device Catalogue Number: 22003E-07
• Device Lot Number: 22039352
• 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: 12/19/2022
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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