MAUDE Adverse Event Report: VYGON MFG 4" MICROBORE EXT SET WITH BIONECTOR; INTRAVASCULAR EXTENSION SET,

Model Number BN-208

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

The device will be returned to vygon for device evaluation as part of the complaint investigation.The results of this investigation will be sent to fda in a follow-up mdr with in thirty days of its conclusion.

Event Description

The tubing part of the set came apart from the end that connects to the iv tubing.It was the line with the white slide clamp.

Manufacturer Narrative

One bn-208 was returned for the complaint of tubing set coming apart from the end that connects to iv tubing (on the white slide clamp side of the set).The issue was found to be confirmed.A review of the lot history record shows no issues that may contribute to this event.The operator and quality personnel who manufactured this product were up to date on all trainings.A sample of each batch is pulled for a destructive tensile testing on this bond joint, and all results were acceptable.The inspection and testing process is applicable for the testing needed to verify an acceptable product build.The root cause for the reported complaint is operator error during the bonding process.Insufficient solvent coverage on the tubing surface from using the roll-on method resulted in poor bonding to the female luer lock component.In reviewing this issue, it was noted that this is the second occurrence of having tubing set loose fitting connection issues for this product (bn-208).There was one found in 2016 and one for 2017.No corrective or preventive actions are required at this time due to the low incidence rate of this failure.Vygon usa will continue to monitor this failure mode for future occurrences.

Event Description

The tubing part of the set came apart from the end that connects to the iv tubing.It was the line with the white slide clamp.

• Brand Name: 4" MICROBORE EXT SET WITH BIONECTOR
• Type of Device: INTRAVASCULAR EXTENSION SET,
• Manufacturer (Section D): VYGON MFG; 87 venture drive; dover NH 03820
• Manufacturer (Section G): VYGON MFG; 87 venture drive; dover NH 03820
• Manufacturer Contact: freda lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 6798715
• MDR Text Key: 82943444
• Report Number: 2245270-2017-00045
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/11/2017

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: BN-208
• Device Lot Number: 1502011D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 08/16/2017
• Supplement Dates Manufacturer Received: 08/10/2017
• Supplement Dates FDA Received: 09/12/2017
• 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