MAUDE Adverse Event Report: VYGON MFG 14" EXTENSION SET; INTRAVASCULAR EXTENSION SET

Model Number AMS-395-1

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Missed Dose (2561)

Event Date 07/24/2014

Event Type  malfunction  

Event Description

Tubing separated from male luer connector with result that infusion leaked out onto bedding.Patient's fentanyl infusion was interrupted for approximately 6 hours with result in loss of pain control.

Manufacturer Narrative

Three pieces of the malfunctioning lot was returned for testing.One piece was a malfunctioning sample two other were unused devices.The unused devices were pull tested with an automatic tester, and all results were within specification.A review of the failed device indicated that the root cause of this nonconformity was due to human error in the application of the solvent bonding solution.The corrective action for this malfunction will be awareness training for all operators involved in the assembly process.Also, the manufacturing staff has been informed to be vigilant to avoid this type discrepancy in the future.

• Brand Name: 14" EXTENSION SET
• Type of Device: INTRAVASCULAR EXTENSION SET
• Manufacturer (Section D): VYGON MFG; dover NH
• Manufacturer Contact: jillian mikovich ; 2750 morris road; suite a200; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 4189990
• MDR Text Key: 5026890
• Report Number: 2245270-2014-00074
• Device Sequence Number: 1
• Product Code: FPK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K884370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AMS-395-1
• Device Lot Number: 1403079
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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: 58 YR
• Patient Weight: 73