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

Catalog Number	20159E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 3 bd smartsite¿ extension set experienced blockage.The following information was provided by the initial reporter: not allowing for fluid flushing.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 22029775.Medical device expiration date: 17-feb-2025.Device manufacture date: 17-feb-2022.Medical device lot #: 21079226.Medical device expiration date: 27-jul-2024.Device manufacture date: 27-jul-2021.Medical device lot #: 21119806.Medical device expiration date: 27-jul-2024.Device manufacture date: 04-nov-2021.
Event or Problem Description
It was reported that 3 bd smartsite¿ extension set experienced blockage.The following information was provided by the initial reporter: not allowing for fluid flushing.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: (b)(6)2022.H6: investigation summary 8 samples 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.The smartsites were then connected to a 10 ml bd syringe filled with blue dye water and the sets were attempted to be flushed.The sets were successfully flushed.The customer complaint that they were unable to be flushed could not be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model 20159e lot number 22029775 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2022.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 20159e lot number 21079226 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2021.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 20159e lot number 21119806 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2021.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.A capa (corrective action preventative action) has been initiated, and a team has been assembled in order to investigate the issue.This incident has been added to our database of reported incidents.

• 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: 15499227
• Report Number: 9616066-2022-01433
• Device Sequence Number: 12223217
• Product Code: FPA
• UDI-Device Identifier: 07613203012270
• UDI-Public: 07613203012270
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/17/2022

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 Catalogue Number: 20159E
• 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: 09/06/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 12/02/2022
• 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