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

Model Number 1252.030G

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hypoglycemia (1912); Premature Labor (2465)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

The failed sample will be returned to vygon for evaluation as 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

Leaking at the wings during picc dressing change was reported.Repair was attempted, not successful.When checked, fluids came out through the end of the shortened catheter.

Manufacturer Narrative

The complaint was forwarded to our parent company in germany for their evaluation.The investigation summary is as follows: we received one catheter as a sample into two pieces.Microscopic examination confirmed that the catheter had been cut with a sharp instrument just proximal the 30 cm marking.This was evident by the visible grooves.Furthermore, the catheter tube had snapped at the 15 cm marking.The rough surface provided visual confirmation of a tensile fracture.The distal part of the catheter tube was missing.Severe occlusions were visible inside the catheter tube.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 first complaint for the involved batches 8070801, 8078460 and 8080362 and the fifth regarding a leaking catheter tube on code 4g07125203 within the last three years.No further corrective action initiated by quality management as the catheter worked well for 13 days and there are no indications of a manufacturing fault.Corrective action: based on the investigation, the reported condition was not related to manufacturing fault.Therefore, no further corrective will be initiated at this time.This failure will be monitored for future actions.

Event Description

Leaking at the wings during picc dressing change was reported.Repair was attempted, not successful.When checked, fluids came out through the end of the shortened catheter.

• Brand Name: NUTRILINE
• Type of Device: LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON USA; 2750 morris road; lansdale PA 19446
• MDR Report Key: 10656367
• MDR Text Key: 210723389
• Report Number: 2245270-2020-00099
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K051690
• 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: 1252.030G
• Device Lot Number: 19J010D OR 19H004D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 7