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
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.¿.
Additional 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
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17450190
• Report Number: 9616066-2023-01612
• Device Sequence Number: 20668027
• Product Code: FPA
• UDI-Device Identifier: 07613203012393
• UDI-Public: (01)07613203012393
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 08/08/2023

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: 20028E
• 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: 07/17/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/23/2023
• 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