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

Model Number 1252.230G

Device Problems Reflux within Device (1522); Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

The failed device will be returned to vygon for evaluation and complaint investigation.The results of this investigation are still pending, and will be communicated to fda within 30 days of its conclusion.

Event Description

Blood reflux into catheter when clamping and removing syringe.

Event Description

Blood reflux into catheter when clamping and removing syringe.

Manufacturer Narrative

The complaint was forwarded to our parent company in germany for their evaluation.The investigation summary is as follows: we received three defective catheters as a sample, two nutriline twinflo and one nutriline.The product incident report (pir) only mentioned nutriline twinflo.All ll-hubs are connected to an external needle free connection system.Additionally, the customer forwarded us three videos of the nutriline twinflo, which show an experimental setup.According to the complaint form, blood reflux occurs when the syringe is removed, even if the extension line is closed by the clamp.Our microscopic examination of the extensions lines reveals several clamping marks.To show that the clamps seal the extension lines completely, and thus no transfer of pressure differences through the clamps is possible, we have conducted leakage tests with positive and negative pressure.All tests were performed both with and without the needle free connection system: · leak-proof in terms of overpressure: a compressed air device for leakage testing is used.The setting parameters correspond to those used during the manufacturing process.· leak-proof in terms of negative pressure: a 10 ml syringe is used to create a vacuum by retracting the piston.In addition, we measured the functional dimensions of the clamps to verify that they were within our specification.Finally, we mimicked the experimental setups from the videos but none of the experiments showed blood reflux.To demonstrate that reflux would have been visible, we took a reference image with aspirated dyed water (open clamps).A review of the batch history records was performed, and no deviations.Each catheter is flow and leak tested during production.Incoming goods inspections and two 100% visual tests after packaging are carried out.The inner and outer diameters of the extension line are monitored during production and lie within our specifications for the involved batches.There is one additional unrelated complaint for batch 8113387 and batch 8093927.There is no additional complaint regarding blood reflux in code 4g07125223.No further corrective action has been initiated by quality management at this time as no defect has been identified.Corrective action: no further corrective action has been initiated by quality management at this time as no defect has been identified.However, both vygon usa and germany will continue to monitor this issue.

• Brand Name: NUTRLNE TWNFLO
• Type of Device: LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON USA; 2750 morris road; lansdale PA 19446
• Manufacturer (Section G): VYGON MFG; 87 venture drive; dover NH 03820
• Manufacturer Contact: freda o lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 12384002
• MDR Text Key: 270279023
• Report Number: 2245270-2021-00103
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1252.230G
• Device Lot Number: 20F020D
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/24/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1