MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD 17 INCH EXT W/.2 FLTR & VLV PORT; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 20028E

Device Problem Material Deformation (2976)

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

Event Date 07/10/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd 17 inch ext w/.2 fltr & vlv port the tubing was damaged.There was no report of patient impact.The following information was provided by the initial reporter: we have 3 low sorb filters with kinks, mfr# 20028, and available for return from the same lot # (10)23019359.Incident report:¿ while priming a 0.2 micron low protein binding filter for a patient about to receive a paclitaxel infusion, rn noticed a defective piece in the tubing right next to filter.Tubing area looked frail and was easily causing a kink in line.Rn quickly grabbed another filter with the same lot number and noticed the same defect.Lot # (10)23019359.¿.

Event Description

It was reported while using bd 17 inch ext w/.2 fltr & vlv port the tubing was damaged.There was no report of patient impact.The following information was provided by the initial reporter: we have 3 low sorb filters with kinks, mfr# 20028, and available for return from the same lot # (10)23019359.Incident report:¿ while priming a 0.2 micron low protein binding filter for a patient about to receive a paclitaxel infusion, rn noticed a defective piece in the tubing right next to filter.Tubing area looked frail and was easily causing a kink in line.Rn quickly grabbed another filter with the same lot number and noticed the same defect.Lot # (10)23019359.¿.

Manufacturer Narrative

H.6.Investigation summary: a complaint of a set easily kinking was received from the customer.No product or photo was returned by the customer.The customer complaint of tubing kinked 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 20028e 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.

• Brand Name: BD 17 INCH EXT W/.2 FLTR & VLV PORT
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17450190
• MDR Text Key: 320772871
• Report Number: 9616066-2023-01612
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012393
• UDI-Public: (01)07613203012393
• 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,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 20028E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2023
• 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