MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 60 IN ULTRA MINIBORE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number ME2017

Device Problems Leak/Splash (1354); Infusion or Flow Problem (2964)

Patient Problem Underdose (2542)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: one sample was received for quality investigation.The customers complaint that the tubing had a crack near the attachment site, which resulted in leaking of the tube, was verified by visual inspection.Cracks on the female luer lock were observed when inspecting the extension set.The cracks come directly from the luer thread engagement location and radiate through the body of the connection.A device history record review could not be performed on model me2017 because a lot number was not provided by the customer.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: although the root cause cannot be definitively determined, excessive tightening the luer connection can cause the cracks seen in the female luer.

Event Description

It was reported 60 in ultra minibore extension set had a crack and leaked.The following information was provided by the initial reporter: material #: me2017 , batch/ lot #: unknown.It was reported that the tubing had a crack near the attachment site, which resulted in leaking of the tube.Crack in medicine tubing at attachment near the medication end.Unsure if all medication was delivered due to the tubing being wet high suspicion for some/all of medication not delivered to patient.The patient is being weaned from this medication currently and the provider has low concern for any adverse outcome to the patient.

• Brand Name: 60 IN ULTRA MINIBORE EXTENSION SET
• 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 22244 ; MX 22244
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 10891578
• MDR Text Key: 246962653
• Report Number: 9616066-2020-20418
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403236240
• UDI-Public: 50885403236240
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051499
• 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: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ME2017
• Device Catalogue Number: ME2017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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