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

Model Number	22003E-07
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 10 bd alaris¿ smartsite¿ extension sets were blocked during use.The following information was provided by the initial reporter: "i have had a department stating that the smartsites are not working correctly and the last 10 or so they have used have not been functioning properly.".
Event or Problem Description
It was reported that 10 bd alaris¿ smartsite¿ extension sets were blocked during use.The following information was provided by the initial reporter: "i have had a department stating that the smartsites are not working correctly and the last 10 or so they have used have not been functioning properly.".
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.It was reported by the customer that the product is not working correctly and/or functioning properly.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 22003e-07 because a lot number is unknown.The root cause of this failure was not identified as no product was returned.Even though no sample/photo was received and failure could not be confirmed, a capa (corrective action preventative action) has been initiated to investigate the customer¿s reported failure mode.A trend for this occlusion issue has been identified for this product line, and a team has been assembled in order to investigate the issue.

• 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 ; 8015296192
• MDR Report Key: 15921232
• Report Number: 9616066-2022-01862
• Device Sequence Number: 11385809
• Product Code: FPA
• UDI-Device Identifier: 50885403242043
• UDI-Public: (01)50885403242043
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 01/27/2023

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: 22003E-07
• Device Catalogue Number: 22003E-07
• 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: 11/10/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 02/14/2023
• 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