MAUDE Adverse Event Report:; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 4063433

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 01/21/2021

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical tubing became disconnected from the patient disconnector.There did not appear to have appropriate bond on the tubing or connector.This was found while the patient was being infused total parental nutrition(tpn).The issue was finally resolved when 3 different sets of tubing were switched out.There were no reported adverse events reported.

Manufacturer Narrative

Other, other text: seventy samples were received.Five of these samples were in used conditions and 65 of them were in unused condition within its original packaging.It could be seen on visual inspection that on 5 of the samples had asv loose from the tube indicating that there was not enough solvent.The failure was confirmed.Based on the analysis conducted with the sample received, the failure could not be reproduced, therefore according with the pfmea the occurrence for this failure condition could be caused by incorrect solvent dispense set up (insufficient solvent in solvent pot).All mitigations on placed were verified and it was confirmed has been executing according, it will be continue monitoring this failure condition in this product for threshold or escalation.Production personnel was notified by quality engineer on (b)(6) 2021 as awareness for the failure mode reported by costumer.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 11296624
• MDR Text Key: 230920577
• Report Number: 3012307300-2021-01019
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 4063433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 15