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	04/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 4-5 bd alaris smartsite extension set experienced occlusion.The following information was provided by the initial reporter: nurses are having trouble priming the extension set.Sometimes they can push and pull and it works.I have 4 extension sets that have staff have had an issue with.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for additional lot number is as follows: medical device lot #: 22029688.Medical device expiration date: 2022-11-02.Device manufacture date: 2021-11-02.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: five samples were returned for investigation.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were 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 smartsite was then connected to a 10 ml bd syringe filled with blue dye water and the set was attempted to be flushed.The set was successfully flushed.The customer complaint that they are having trouble priming the extension set could not be replicated.Following a small number of similar reports, bd has conducted an in-depth investigation to identify any potential contributing factors for occlusion of this nature.The investigation has determined that a potential contributor could be the result of an insufficient amount of fluorosilicone having been injected into the piston during the assembly process.A device history record review for model 22003e - 07, lot number: 21119801 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 04nov2021.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: 22029688 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 12feb2022.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) 1998036 has been initiated, and a team has been assembled in order to investigate the issue.
Event or Problem Description
It was reported that 4-5 bd alaris smartsite extension set experienced occlusion.The following information was provided by the initial reporter: nurses are having trouble priming the extension set.Sometimes they can push and pull and it works.I have 4 extension sets that have staff have had an issue with.

• 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: 14342200
• Report Number: 9616066-2022-00562
• Device Sequence Number: 12448414
• Product Code: FPA
• UDI-Device Identifier: 50885403242043
• UDI-Public: 50885403242043
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2022

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: 21119801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 05/27/2022
• 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