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

Catalog Number 2426-0500

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: one sample was received for quality investigation.The customers complaint of the alaris tubing was not attached to the y-site was verified by visual inspection.The submitted sample was received with the tubing separated from the smartsite y-site.Further investigation indicates that the tubing was not inserted fully into the smartsite y-site opening.A device history record review for model 2426-0500, lot number 20073445 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 28jul2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this complaint is an error at the manufacturing facility.The tubing was not inserted with the adequate depth into the smartsite y-site and therefore separated.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 v/nv ckv 3 ss 20dp 20pk experienced component separation.The following information was provided by the initial reporter: material #: 2426-0500.Batch/ lot #: 20073445.Bd alaris pump infusion set was faulty.Rn pulled tubing out of packaging and the tubing that is supposed to be attached to the y-site was not attached making the tubing unable to be used.Rn got another package of tubing and everything was ok with the second package of tubing.We have had quite a bit of this tubing that either leaks or tubing is apart in package.

• Brand Name: GEM V/NV CKV 3 SS 20DP 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: 11103077
• MDR Text Key: 249394358
• Report Number: 9616066-2020-20702
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203020992
• UDI-Public: 07613203020992
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/28/2023
• Device Catalogue Number: 2426-0500
• Device Lot Number: 20073445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2020
• 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