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

Catalog Number	20519E
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set came apart during use and leaked medication down the patient's back.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "the manifolds have been coming apart and leaking, and the connection with the extension to the angio seems to not screw on very tight and leaks at that spot.Bd smartsite ext set 3 port manifold - # 20519e coming apart where circled and air locking.Details: pt.Was in endo being put to sleep and the anesthesia provider stated that the connection of item 7592897 to the angio was leaking.He tightened that connection then went to the manifold ((b)(6)), started giving propofol and the connection there came apart completely and sprayed the patient down her back.There was no adverse event.It just delayed the patient getting to sleep for the procedure.Procedure: egd and colonoscopy".
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set came apart during use and leaked medication down the patient's back.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "the manifolds have been coming apart and leaking, and the connection with the extention to the angio seems to not screw on very tight and leaks at that spot.Bd smartsite ext set 3 port manifold - # 20519e â¿¿ coming apart where circled and air locking.*details: pt.Was in endo being put to sleep and the anesthesia provider stated that the connection of item 7592897 to the angio was leaking.He tightened that connection then went to the manifold (7570763), started giving propofol and the connection there came apart completely and sprayed the patient down her back.There was no adverse event.It just delayed the patient getting to sleep for the procedure.*procedure: egd and colonoscopy.".
Additional Manufacturer Narrative
Investigation summary: no product was returned by the customer.Photo received for verification.It was reported by the customer that the manifolds have been coming apart and leaking could not be verified due to the product not being returned for failure investigation and the photo could not verify the complaint.The root cause cannot be determined without the physical sample for investigation.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• 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 ; 8448235433
• MDR Report Key: 16770314
• Report Number: 9616066-2023-00723
• Device Sequence Number: 3237748
• Product Code: FPA
• UDI-Device Identifier: 10885403234941
• UDI-Public: 10885403234941
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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): 05/10/2023

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: Health Professional
• Device Catalogue Number: 20519E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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