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

Model Number 2420-0500

Device Problems Backflow (1064); Leak/Splash (1354)

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

Event Date 06/11/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a complaint of disconnected tubing on the set was received from the customer.No product or photo was returned by the customer.The customer complaint of component damage 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 2420-0500 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: no product will be returned per customer.No investigation was performed.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, flow issues, and was cracked.The following information was provided by the initial reporter: patient asking writer if "this chemotherapy stains?" writer asked for further clarification, and pt showed writer their shirt.It has a twoonie sized caelyx (red-orange) - colored stain on the shirt sleeve upon doing the d5w flush- no chemo noted on skin.Lines clamped & assistance obtained.Tubing disconnected and noted that there was a crack in the rescue line tubing and caelyx had backed up (small amount) into the tubing.New line applied to y site & iv intact.We cleansed pt's skin & discarded the shirt in biohazard bucket giving them a hospital gown.Pt up to bathroom to scrub hands.Level of harm: no apparent harm - reached patient/person, inconvenient.

• 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
• 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: 12181698
• MDR Text Key: 261976565
• Report Number: 9616066-2021-51532
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203012448
• UDI-Public: 37613203012448
• 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: 06/18/2021

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
• Device Operator: Other
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/16/2021
• 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