MAUDE Adverse Event Report: VYGON USA BIFUR T-PORT EXT SET; ADMINISTRATION SET

Model Number AMS-884-2T

Device Problems Crack (1135); Material Integrity Problem (2978)

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

Event Date 11/07/2022

Event Type  malfunction  

Manufacturer Narrative

The failed device will be returned for evaluation, the details of the malfunction will be evaluated 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 md.

Event Description

Cracking collar and top of threaded connector.

Manufacturer Narrative

Samples were sent by the customer.The complaint states that the "collar was cracked".Visual inspection of the product returned shows that the luer lock was over-torqued and thus cracked and became disengaged.This complaint is confirmed.However, to test the functionality, the samples sent that were unopened/uncontaminated were connected to a 10 ml prefilled saline syringe to simulate use and observe any issues.This complaint cannot be confirmed, as no cracks, leaking, or other issues were found.Quality inspection records for lot 2204023d was reviewed for any abnormalities, inconsistencies, or nonconformities that may have caused or contributed to the reported condition.A total lot quantity of (b)(4) sets was produced whereas (b)(4) sets were leak and occlusion tested, and (b)(4) samples were pulled for bond pull testing.There were no failures identified in the aql in-process testing.In addition, incoming inspection records showed no abnormalities were observed when the product was inspected upon receipt.Root cause: it is believed that the cracked failure is due to over-tightening the luer lock and thus causing a crack and disengagement.If this is a manufacturing problem, this issue should be detected by the assembler during the solvent bonding and packaging process.Corrective action: it is believed that this failure is due to over-tightening the luer lock and thus causing a crack and disengagement.Therefore, no corrective actions will be implemented at this time.It is recommended to use caution when tightening the luer to avoid cracking.

Event Description

Cracking collar and top of threaded connector.

• Brand Name: BIFUR T-PORT EXT SET
• Type of Device: ADMINISTRATION SET
• 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: 15998179
• MDR Text Key: 308255519
• Report Number: 2245270-2022-00108
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021395
• 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: 01/10/2023

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-884-2T
• Device Lot Number: 2204023D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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
• Patient Age: 5 MO
• Patient Sex: Male