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	04/20/2022
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 at least one bd alaris smartsite extension set was clogged.The following information was provided by the initial reporter: we've had several failed extension sets.
Event or Problem Description
It was reported that at least one bd alaris smartsite extension set was clogged.The following information was provided by the initial reporter: we've had several failed extension sets.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.4.Medical device lot #: 21089080; d.4.Medical device expiration date: 31-aug-2022; h.4.Device manufacture date: 31-aug-2021; d.4.Medical device lot #: 21129217; d.4.Medical device expiration date: 31-aug-2022; h.4.Device manufacture date: 31-aug-2021.D.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 29-apr-2022.H.6.Investigation: 10 samples model 22003e - 07 were returned for investigation( 3 used, 1 unused samples lot21089080 and 6 unused samples lot21129217).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 all but 1 used sample lot21089080.The smartsites were then connected to a 10 ml bd syringe filled with blue dye water and the sets were attempted to be flushed.All sets were successfully flushed except for 1 used lot 21089080 sample.The customer complaint that the extension sets failed could be replicated for one of the returned samples.The root cause is unknown.A device history record review for model 22003e - 07 lot number 21089080 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 22003e - 07 lot number 21129217 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.

• 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: 14365332
• Report Number: 9616066-2022-00582
• Device Sequence Number: 20279228
• 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: Other
• Device Expiration Date: 08/31/2022
• Device Model Number: 22003E-07
• Device Catalogue Number: 22003E-07
• Device Lot Number: SEE H.10
• 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: 04/20/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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