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

Catalog Number	20059E
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.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 the bd smartsite¿ extension set experienced difficulty to disconnect device.The following information was provided by the initial reporter: there was a massive recall from 2021 indicating difficulty in opening the needle free connection.
Event or Problem Description
It was reported that the bd smartsite¿ extension set experienced difficulty toto disconnect device.The following information was provided by the initial reporter: there was a massive recall from 2021 indicating difficulty in opening the needle free connection.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 06-jul-2023.H6: investigation summary: two samples of item number 20059e were submitted for quality investigation.The customer complaint of needle free connection issues could not be verified by inspection and testing.The samples submitted were visually examined for any damages to the components.No damages were identified during the visual inspection.The samples where then connected to a needle free syringe filled with water and a flush was attempted on the sample.The connection between the needle free syringe and extension set did not show any signs of leakage and there was no occlusion of flow.No further issues were identified during evaluation.A device history record review for model 20059e lot number 22119362 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause was not determined because the reported failure could not be replicated with the sample submitted.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17221406
• Report Number: 9616066-2023-01292
• Device Sequence Number: 6185928
• Product Code: FPA
• UDI-Device Identifier: 07613203012317
• UDI-Public: 07613203012317
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/13/2023

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: 01/18/2026
• Device Catalogue Number: 20059E
• Device Lot Number: 23019219
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• 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