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 Patient Involvement (2645)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Fda device problem code(s): 1354, fda patient problem code(s): 2645.

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: complaint 1 of 2 material #: 2426-0500 batch/ lot #: 20073206 the nurse took the package off the shelf and opened the package and a part of the iv tubing fell on the floor because it was not connected to the tubing.

Manufacturer Narrative

H.6.Investigation: a sample was received and investigated by our quality team.The customer's complaint of separation was immediately apparent and the complaint has been verified.The sample was visually analyzed using microscope and a lack of solvent was noticed at tubing section inserted in junction.This is the root cause of the failure.Tubing was measured to be within od specifications.A device history record review for model 2426-0500 lot number 20073206 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of separation with lot #20073206 regarding item #2426-0500.

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: complaint 1 of 2 material #: 2426-0500, batch/ lot #: 20073206.The nurse took the package off the shelf and opened the package and a part of the iv tubing fell on the floor because it was not connected to the tubing.

• 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
• MDR Report Key: 11103500
• MDR Text Key: 224796771
• Report Number: 9616066-2020-20710
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203020992
• UDI-Public: 07613203020992
• 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,Followup
• Report Date: 02/09/2021

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 Expiration Date: 07/12/2023
• Device Catalogue Number: 2426-0500
• Device Lot Number: 20073206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1