MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEC SET 20DP 30IN W/HANGER LL; INTRAVASCULAR ADMINISTRATION SET

Model Number 72213N

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device lot #: actual lot number is unknown, however the customer suspects lot 21049530 (mfg: 04/19/2021 exp: 04/19/2024).Device manufacture date: unknown.Investigation summary: a complaint of a set having a hole and leaking 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 potential lot number was provided and device history record review was performed.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.

Event Description

It was reported sec set 20dp 30in w/hanger ll was damaged, causing leakage.The following information was provided by the initial reporter: "while prepping chemotherapy to hang on other primary, i noticed that the leucovorin was dripping and leaking due to chamber having a hole.".

• Brand Name: SEC SET 20DP 30IN W/HANGER LL
• 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
• MDR Report Key: 12652196
• MDR Text Key: 277133714
• Report Number: 9616066-2021-52247
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203010086
• UDI-Public: 37613203010086
• Combination Product (y/n): N
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 72213N
• Device Catalogue Number: 72213N
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2021
• 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