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

Model Number	20350ET
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd smartsite¿ extension set the components separated.There was no report of patient impact.The following information was provided by the initial reporter: we open a new in-line filter yesterday (b)(6) 2023, and it came broken around the discs area.
Additional Manufacturer Narrative
H.3: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 12-may-2023.Investigation summary: a complaint of filter being received broken was received from the customer.A sample was returned for investigation.Through visual inspection, the defect was confirmed.The set had separated at the lower part of the filter due to damage.The piece where the tubing connects to the filter had broken off into the tubing.A device history record review for model 20350et, lot number 21079233 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.It was determined that this defect was a supplier issue.The supplier of this filter was also notified of this defect.An investigation of the sample was performed by the supplier.Due to the damage of filter, and the piece being fully broken off inside the tubing, it was determined that the filter was broken at the time of the set assembly.The root cause of the damage could not be determined.
Event or Problem Description
It was reported while using bd smartsite¿ extension set the components separated.There was no report of patient impact.The following information was provided by the initial reporter: we opened a new in-line filter yesterday 4/25/2023, and it came broken around the discs area.

• 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 ; 8448235433
• MDR Report Key: 16962170
• Report Number: 9616066-2023-00949
• Device Sequence Number: 5237839
• Product Code: FPA
• UDI-Device Identifier: 50885403229754
• UDI-Public: (01)50885403229754
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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): 08/29/2023

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: 07/30/2024
• Device Model Number: 20350ET
• Device Catalogue Number: 20350ET
• Device Lot Number: 21079233
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2021
• 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