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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that unspecific number of bd alaris¿ smartsite¿ extension set experienced leakage.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: there was another instance in endo that the manifold connection came loose and was leaking but did not come completely apart.There were several instances that the extension to the angiocath would be leaking, and the nurses had to change the dressing and tighten the connection.There was no adverse event.It just delayed the patient getting to sleep for the procedure.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.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.
Additional Manufacturer Narrative
H6: 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.
Event or Problem Description
It was reported that unspecific number of bd alaris¿ smartsite¿ extension set experienced leakage.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: there was another instance in endo that the manifold connection came loose and was leaking but did not come completely apart.There were several instances that the extension to the angiocath would be leaking, and the nurses had to change the dressing and tighten the connection.There was no adverse event.It just delayed the patient getting to sleep for the procedure.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16770442
• Report Number: 9616066-2023-00724
• Device Sequence Number: 6436905
• Product Code: FPA
• UDI-Device Identifier: 10885403234941
• UDI-Public: (01)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