MAUDE Adverse Event Report: VYGON GMBH LEADERFLEX; INTRAVASCULAR CATHETER

Model Number 1212.20

Device Problems Break (1069); Material Separation (1562)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

The failed sample was not returned to vygon for evaluation but the events will be part of the complaint investigation.The results of this investigation are still pending and will be communicated to fda within 30 days of its conclusion.

Event Description

Midline came apart at injection cap connection site.

Manufacturer Narrative

This complaint could not be classified as we did not receive a sample for evaluation.Two photographs were received for review; no physical sample was returned to the manufacturer for investigation.A review of the photographs provided by the account shows that the extension line came off the ll-hub.The proximal end (estimated via photograph around 1 cm) of the extension lines looks as if the surface's structure of the tube is different to the rest of the tube.This could indicate that the tube in this area was previously in the ll-hub, it had been over molded correctly and was pulled out of the hub by applying high forces.A review of the batch history records showed no deviations.Each catheter is flow and leak tested during production.The tensile force of the catheter components is randomly checked.Incoming goods inspections and two 100% visual tests after packaging are carried out.The tensile force of extension line/ll-hub for the involved batch was between 20,1 n and 47,0 n and therefore within our specification (min.15 n).This is the very first complaint for batch 110220gh and the very first complaint regarding an extension line coming off the ll-hub on code 1212.20 within the last three years.No further corrective action initiated by quality management due to the missing sample, no root cause analysis can be made.Corrective action: no further corrective action initiated by quality management due to the missing sample.However, both vygon usa and germany will continue to monitor this issue.

Event Description

Midline came apart at injection cap connection site.

• Brand Name: LEADERFLEX
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON GMBH; prager ring 100; aachen 52070 ; GM 52070
• MDR Report Key: 10656209
• MDR Text Key: 210656790
• Report Number: 2245270-2020-00088
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: ) K141026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

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: No Information
• Device Model Number: 1212.20
• Device Catalogue Number: 1212.20
• Device Lot Number: 110220GH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 08/26/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1