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

Catalog Number 2426-0500

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.Initial reporter facility name: uw health ¿ university hospital and american family children¿s hospital.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the gem v/nv 20dp ckv 2ss 117-in 20pk experienced leakage.The following information was provided by the initial reporter: complaint 1 of 2 material #: 2426-0500.Lot#: unknown.Tubing started leaking at a connection by a port during an infusion.Rn alerted by parent of a patient receiving an infusion.

Event Description

It was reported that the gem v/nv 20dp ckv 2ss 117-in 20pk experienced leakage.The following information was provided by the initial reporter: complaint 1 of 2.Material #: 2426-0500 lot#: unknown.Tubing started leaking at a connection by a port during an infusion.Rn alerted by parent of a patient receiving an infusion.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-12-17.Investigation summary : one sample was received for quality investigation.The customer complaint of the tubing leaking at a connection by a port could not be verified by inspection.Visual inspection of the infusion set did not reveal any visible cuts or pinhole in the tubing, and there were not cracks in the components, however, the lower luer lock fitting was missing from the infusion set.A simulated infusion was then conducted to determine if any leakage can be observed.There was no signs of leakage throughout the entire infusion set.A device history record review could not be performed on model 2426-0500 because a lot number was not provided by the customer.A root cause was not established because the failure mode could not be replicated.

• 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 22244 ; MX 22244
• MDR Report Key: 11092247
• MDR Text Key: 249046143
• Report Number: 9616066-2020-20680
• 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: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2426-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1