MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. LARGEBORE 8 INCH EXT VLV; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 20059E

Device Problem Stretched (1601)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2021

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: a photo was received for quality investigation.The customer complaint of component damage - no leak was verified by photo inspection.No further defects or damage can be determined based on the photo provided.A device history record review could not be performed on model 20059e 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.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: a photo was received for quality investigation.The customer complaint of component damage - no leak was verified by photo inspection.No further defects or damage can be determined based on the photo provided.No product will be returned per customer.No investigation was performed.

Event Description

It was reported that 2 largebore 8 inch ext vlv experienced tubing expansion/ballooning/bulging.The following information was provided by the initial reporter: material #: 20059e, batch/ lot #: unknown.It was reported that the extension tubing that was used burst while receiving contrast.The extension tubing was used during a cta and burst while receiving the contrast.

• Brand Name: LARGEBORE 8 INCH EXT VLV
• Type of Device: 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11588855
• MDR Text Key: 244481372
• Report Number: 9616066-2021-50604
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 20059E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1