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

Model Number	20019E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd smartsite¿ extension set pressure rated smallbore bifuse component separated.There was no report of patient impact.The following information was provided by the initial reporter: i have a broken microbore extension set that was on a patient.The part is: ref# (b)(4).It looks like it was a defect where it slipped right out of the neck.
Additional Manufacturer Narrative
The following are possible lots #: d4: medical device lot #: 22115490.D4: medical device expiration date: 12-jan-2026.H4: device manufacture date: 12-jan-2023.D4: medical device lot #: 23015302.D4: medical device expiration date: 17-jan-2026.H4: device manufacture date: 17-jan-2023.D4: medical device lot #: 23015251.D4: medical device expiration date: 12-jan-2026.H4: device manufacture date: 12-jan-2023.D4: medical device lot #: 23015268.D4: medical device expiration date: 12-jan-2026.H4: device manufacture date: 12-jan-2023.The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 15-jun-2023.H6: investigation summary.One sample was received and tested by our quality team.The male luer collar was separated and attached to a blue cap upon receipt and the complaint can be verified.The male luer collar was unscrewed and re attached to set.The re assembled set was tested and no connection or leak issue realized.The blue cap included was then screwed back on the male luer end and the collar popped back off.This type of cap is not recommended with this set and should not be used for this purpose.The root cause is due to user error/ improper use of device.A device history record review was performed and there were no relevant production issues or quality notifications with the mat # 20019e sets of the following lots: 22115490, 23015302, 23015251, and 23015268.
Event or Problem Description
It was reported while using bd smartsite¿ extension set pressure rated smallbore bifuse component separated.There was no report of patient impact.The following information was provided by the initial reporter: i have a broken microbore extension set that that was on a patient.The part is: ref# (b)(4).It looks like it was a defect where it slipped right out of the neck.

• Brand Name: BD SMARTSITE¿ EXTENSION SET PRESSURE RATED SMALLBORE BIFUSE
• 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: 17167591
• Report Number: 9616066-2023-01218
• Device Sequence Number: 5589893
• Product Code: FPA
• UDI-Device Identifier: 27613203013813
• UDI-Public: (01)27613203013813
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061285
• 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): 07/28/2023

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 Model Number: 20019E
• Device Catalogue Number: 20019E
• Device Lot Number: UNKNOWN
• 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: 05/25/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 08/15/2023
• 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