MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM 20DP CKV 3SS DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number 2426-0007

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

Date of birth: only the patient's age was provided, therefore a default date of birth has been listed.Fda notified: the initial reporter also notified the fda via medwatch # (b)(4).Investigation summary: a complaint of a white substance being found in the male luer, making it difficult to connect to another set was received from the customer.A sample was returned for investigation.Through visual inspection the customer complaint was confirmed.There was a white piece of matter stuck in the male luer.An ftir analysis was performed on the sample.The foreign matter is most likely dihydrocarvone, an additive commonly used in the food and flavor industry.A secondary set was attached to the set easily, but was very difficult to disconnect.A device history record review for model 2426-0007 lot number 21045794 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 13apr2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the foreign matter was an error in the manufacturing process.The foreign matter is the cause for the connection issues.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 that the gem 20dp ckv 3ss dehp free experienced foreign matter in fluid pathway.The following information was provided by the initial reporter: rn priming iv tubing with normal saline.After primed, it went to connect to patient's peripheral iv.Unable to connect posi flow to tubing connection end.Rn assess the tubing and found there was a piece of hard plastic noted in the luer lock connection piece.

• Brand Name: GEM 20DP CKV 3SS DEHP FREE
• 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: 12465170
• MDR Text Key: 271264759
• Report Number: 9616066-2021-52031
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403227996
• UDI-Public: 50885403227996
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 21045794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Date Manufacturer Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2021
• 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
• Patient Age: 22 YR