MAUDE Adverse Event Report: VYGON USA EXTENSION SET; INFUSION LINE

Model Number AMS-427

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

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

Event Date 11/05/2022

Event Type  malfunction  

Manufacturer Narrative

There were three (3) occurrences within this complaint.Those occurrences were captured in the following mdrs: 2245270-2022-00111.The failed devices were returned to vygon for evaluation as part of the complaint investigation.The results of this investigation are still pending and will be reported to fda within thirty days of its conclusion via follow-up mdr.

Event Description

Cracking in filters.

Manufacturer Narrative

There were three (3) occurrences within this complaint.Those occurrences were captured in the following mdrs: 2245270-2022-00110, 2245270-2022-00111, 2245270-2022-00112.Three (3) ams-427 with lot number 2111038d were returned for investigation.The returned set were visually examined to identify any obvious non-conformity relating to the customer claim.We performed a functional test for each sample by using the 10 ml prefilled syringe of sodium chloride to the proximal end of this set and pressurizing the set to help determine the actual location of the suspected leakage.No leaks were observed.Therefore, the issue remains unconfirmed.Corrective action: based on the investigation, this issue could not be confirmed.Therefore, no corrective action will be initiated at this time.Vygon usa will continue to monitor for this issue and escalate as appropriate.

Event Description

Cracking in filters.

• Brand Name: EXTENSION SET
• Type of Device: INFUSION LINE
• 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: 15998361
• MDR Text Key: 305637636
• Report Number: 2245270-2022-00110
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K894954
• 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: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AMS-427
• Device Lot Number: 2111038D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2022
• 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