MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20DP CKV 2SS 117-IN 20PK; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2420-0500

Device Problem Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: no product or photo was returned by the customer.The customer complaint of dripping from the tubing between the safety clamp and roller clamp could not be verified due to the product not being returned for failure investigation.A device history record review for model 2420-0500, lot number 20063012 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 12jun2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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: due to no sample being received, an investigation could not be performed and a root cause could not be determined.

Event Description

It was reported that the gem v/nv 20dp ckv 2ss 117-in 20pk experienced leakage.The following information was provided by the initial reporter: material no: 2420-0500, batch no: 20063012.Date of incident (yyyy-mm-dd): 2020 (b)(6).Chemotherapy noted to be dripping from the tubing between the safety clamp and roller clamp at the point of the collar.Chemo spill protocol followed.Risk of exposure to staff.Patient missed part of treatment.Who was affected? patient.

• Brand Name: GEM V/NV 20DP CKV 2SS 117-IN 20PK
• 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: 11233986
• MDR Text Key: 229389785
• Report Number: 9616066-2021-50104
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: 07613203012430
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/12/2023
• Device Catalogue Number: 2420-0500
• Device Lot Number: 20063012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2020
• 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