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

Model Number VYPL4S3003A

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 occurrences within this complaint.Those occurrences were captured in the following mdrs: 2245270-2022-00032, 2245270-2022-00033.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.

Manufacturer Narrative

There were three (3) occurrences within this complaint.Those occurrences were captured in the following mdrs: 2245270-2022-00032, 2245270-2022-00033, 2245270-2022-00034.The supplier was contacted for an investigation and response.The response is as follows: no samples or pictures were provided for evaluation.Investigation was performed based on information available.During analysis it was found that the reported lots were manufactured and inspected according to standard operation procedures.The affected part numbers and lot numbers were received from an external supplier, incoming inspection personnel inspected the material according to (b)(4).Applying an aql c=0/1.0 in total 50 pieces out of 6,050 purchased tubes were inspected for visual criteria where tube shall not be discolored, must be free of water marks, clear, without any kinks or bends that restrict the id, no sharp and no bumps and per dimensional criteria tubes were measured per total length, id (inside diameter) and od (outside diameter); during incoming inspection no issues related to failure mode reported were found on lot reviewed.The involved lots were arrived with certificate that includes a report provided by supplier.In these reports indicates that material is formulated in accordance with the specification of materials and methods of the original submission of the same product.The affected lot were also inspected during final inspection, where inspector verified per correct components, locking hub configuration, hub colors and french sizes and transition; and no issues related to failure mode reported (catheter sheath corrugated from tip) was detected.The customer was not able to provide a photo for the complaint and discarded the sample; therefore, investigation conducted per dhrs review.Based on dhr review, process review, it is concluded that failure mode "the introducer gets caught on the skin or vein wall and bunches like and accordion" is not attributable to our manufacturing process.A review of vygon's complaints showed there were three complaints with the introducer peeling over the past two years.All three complaints came from the same customer.Corrective action: based on the investigation, the reported failure mode was not related to suppliers manufacturing process.Therefore, no corrective action will be initiated at this time.

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.

• Brand Name: 4FR SINGLE PICC 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: 14631486
• MDR Text Key: 293557693
• Report Number: 2245270-2022-00034
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): Y
• 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: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VYPL4S3003A
• Device Catalogue Number: VYPL4S3003A
• Device Lot Number: 21K024D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 05/26/2022
• Supplement Dates FDA Received: 07/20/2022
• 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