MAUDE Adverse Event Report: VYGON USA NUTRILINE 24G (2FR) CATHETER WITH STYLET AND MICROFLASH INTRODUCER; INTRAVASCULAR CATHETER

Model Number 1252.030G

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

The failed sample was 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

The picc was found to be cracked and leaking on same day as insertion.The picc rn was called in to assess the line, called for full retape, and noted fluids on the steri strips.The skin was cleaned with chlorohexidine after the leak was found.The line was removed and replaced with multiple iv's.

Manufacturer Narrative

The investigation summary is as follows: the returned sample was leaking just distal the wing when flushed.Microscopic examination showed a little hole/tear at the junction of the catheter tube and wing.Typical signs for a stressed catheter were visible.The customer stated "please note leaking was noted prior to the cleansing of the skin," in the complaint, however it was unclear how the skin had been cleansed prior to inserting the catheter.In a later email it was reported that the customer was using an alcohol-based chlorhexidine as a disinfectant : "we use chlorhexidine swab to prep the skin prior to insertion allow to dry then place the lines." the catheter tube should never be exposed to tensile stress and/or alcoholic agents at any time.Having checked batch history records, no deviations were found.Each catheter is flow and leak tested during production.The tensile force of the catheter components is randomly checked.Visual tests and incoming goods inspections are carried out.This is the second complaint for batch 8027354 and the fourth regarding leakages on code 4g07125203.Since each catheter is leak and flow tested before packaging, and the catheter had obviously been stressed, we do not believe that the leak was due to a manufacturing error.No further corrective action will be initiated at this time.Vygon will continue to monitor for this issue.

Event Description

The picc was found to be cracked and leaking on same day as insertion.The picc rn was called in to assess the line, called for full retape, and noted fluids on the steri strips.The skin was cleaned with chlorohexidine after the leak was found.The line was removed and replaced with multiple iv's.

• Brand Name: NUTRILINE 24G (2FR) CATHETER WITH STYLET AND MICROFLASH INTRODUCER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON USA; 2750 morris road; lansdale PA 19446
• MDR Report Key: 9268007
• MDR Text Key: 165038202
• Report Number: 2245270-2019-00071
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1252.030G
• Device Lot Number: 18F024D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1