MAUDE Adverse Event Report: VYGON USA 4F SINGLE MIDLINE MAX BARRIER KIT; LONG-TERM INTRAVASCULAR CATHETER

Model Number VYML4S3001S

Device Problems Degraded (1153); Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2022

Event Type  malfunction  

Manufacturer Narrative

There were three (3) occurrences within this complaint.Those occurrences were captured in the following mdrs: 2245270-2022-00037 and 2245270-2022-00038.Although no device was returned for evaluation, the details of the malfunction will be evaluation as part of the complaint investigation.The results of the investigation are still pending and will be communicated to fda within thirty days of its conclusion via follow-up mdr.

Event Description

The introducer gets caught on the skin or vein wall and bunches like and accordion.Or the edge of the introducer starts to peel back like a banana.

Event Description

The introducer gets caught on the skin or vein wall and bunches like and accordion.Or the edge of the introducer starts to peel back like a banana.

Manufacturer Narrative

There were three (3) occurrences within this complaint.Those occurrences were captured in the following mdrs: 2245270-2022-00036, 2245270-2022-00037, 2245270-2022-00038.The supplier was contacted for an investigation and response.The response is as follows: we purchased (2313) units of dss-010-045 (prcgm038862) and (prcgm038863) from approved supplier; however (2000) units shipped to vygon us and the remainder units shipped to other customers.Vygon us had two complaints for the product, saturation level for the occurrence is 0.1%.We did not receive any complaint for the remainder units that have been shipped to other customers; therefore, overall saturation level is 0.08%.No adverse event occurred according to the customer.Dhrs has been reviewed for main product and subcomponents; there was no abnormality or nonconformance recorded.All parts manufactured according to internal drawings.The customer was not able to provide a photo for the complaint and the end user discarded the sample; therefore, investigation conducted per dhrs review.Investigation per dhr shows that there were no abnormality or discrepancy during manufacturing process.We can't perform evaluation without complaint sample, this complaint can't be confirmed.Device history record shows that all processes were performed as specified.Device history record shows that all equipment and material used are as specified.No incidents recorded at time of manufacture.A review of vygon's complaints showed this is the second issue with the introducer peeling associated with this product code over the past two years.Corrective action: due to the missing sample, the root cause of this issue could not be confirmed.Therefore, no corrective action will be initiated at this time.This failure will be monitored for future actions.

• Brand Name: 4F SINGLE MIDLINE MAX BARRIER KIT
• 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: 14635349
• MDR Text Key: 302607700
• Report Number: 2245270-2022-00036
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172899
• 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: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VYML4S3001S
• Device Lot Number: 21G033D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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