MAUDE Adverse Event Report: VYGON USA PREMICATH; LONG-TERM INTRAVASCULAR CATHETER

Model Number 1261.20G

Device Problem Fluid/Blood Leak (1250)

Patient Problems Premature Labor (2465); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2020

Event Type  malfunction  

Manufacturer Narrative

Two occurrences of this malfunction were reported to vygon, the details of the other can be found in mdr: 2245270-2020-00095.Samples will be returned to vygon and will be evaluated as part of the complaint investigation.The results of this investigation are still pending and will be communicated with fda within 30 days of completion.

Event Description

They were found to be leaking from the same spot, the location between the catheter and the butterfly.

Manufacturer Narrative

The complaint was forwarded to our parent company in vygon germany for their evaluation.The investigation summary is as follows: we received two samples for this complaint.Both were immediately leaking at the junction of catheter tube and extension line/wing when flushing them.Microscopic examination confirmed a little radial tear and showed that each catheter tube was partly torn out of the junction to the extension line/fixation wing.From previous complaints we learn of various possible causes of leakages at the catheter junction to the extension line/fixation wing.Most of them were related to tensile traction under influence of the use of alcohol-based disinfectants.Furthermore, both samples were very sticky due to residues of plaster which obviously adhered to the catheter tube and wing.Per customer, chloraprep had been used as disinfectant which contains 70% alcohol.We have a warning leaflet in each blister which declares: "never use organic solvents such as alcohol directly on the catheter, it may weaken the material.If an alcohol-based disinfectant is used on the insertion skin area, it must dry completely before exposing the catheter to any mechanical stress." the product's ifu also specifically suggests: "carefully clean the insertion site and position drapes.The puncture may only be made after the disinfectant has been completely dried on the skin.Be aware that organic solvents such as alcohol or acetone may interact with catheter material and weaken it." 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 are performed after product is packaged.This is the fourth complaint for the involved batches 8082677 and 8090698 and the third regarding a leaking catheter tube on code 4g07126120 within the last three years.As the catheter worked well for 15 days and 36 days, we do not believe this is a manufacturing fault and no further corrective action is initiated by quality management corrective action: based on the investigation, this issue could not be determined to be caused by manufacturing; therefore, no further corrective action will be initiated at this time.Both vygon usa and germany will continue to monitor this issue.

Event Description

They were found to be leaking from the same spot, the location between the catheter and the butterfly.

• Brand Name: PREMICATH
• Type of Device: LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON USA; 2750 morris road; lansdale PA 19446
• MDR Report Key: 10656288
• MDR Text Key: 210717423
• Report Number: 2245270-2020-00094
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K954302
• 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: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1261.20G
• Device Lot Number: 19L003D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1