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

Catalog Number	30204E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.Investigation summary - a complaint of tubing splitting causing leakage was received from the customer.No product or photo was returned by the customer.The customer complaint of component damage - leak 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 30204e because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set was damaged causing leakage.The following information was provided by the initial reporter: er and ct have noted an occurrence of tubing leaking /split after patient had high pressure injection thru the tubing: 30204e extension tubing is split/leaking from the flexible plastic tubing closest to patient end.Ct tech have had to change over the tubing.
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set was damaged causing leakage.The following information was provided by the initial reporter: er and ct have noted an occurrence of tubing leaking /split after patient had high pressure injection thru the tubing: 30204e extension tubing is split/leaking from the flexible plastic tubing closest to patient end.Ct tech have had to change over the tubing.
Additional Manufacturer Narrative
H6: investigation summary a complaint of tubing splitting causing leakage was received from the customer.No product or photo was returned by the customer.The customer complaint of component damage - leak 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 30204e because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.H3 other text : see h10.

• 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: 16592940
• Report Number: 9616066-2023-00538
• Device Sequence Number: 5326205
• Product Code: FPA
• UDI-Device Identifier: 10885403235177
• UDI-Public: 10885403235177
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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 Catalogue Number: 30204E
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 04/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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