MAUDE Adverse Event Report: VYGON MFG LIFEGUARD; SAFETY HUBER NEEDLE

Catalog Number CLGY-2034

Device Problem Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

Please see mdr 2245270-2017-00030 for data for an additional occurence of this malfunction with this customer.The malfunctioning device was returned to vygon for evaluation as part of the complaint investigation.The results of this investigation are still pending and will be communicated to fda within thirty days of its conclusion via follow-up mdr.

Event Description

Safety malfunction: the needle protrudes through the safety cap which is a potential hazard to the nurse handling the needle for risk of being stuck by a contaminated needle.

• Brand Name: LIFEGUARD
• Type of Device: SAFETY HUBER NEEDLE
• Manufacturer (Section D): VYGON MFG; 87 venture drive; dover NH 03820
• Manufacturer (Section G): VYGON MFG; 87 venture drive; dover NH 03820
• Manufacturer Contact: jillian mikovich ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 6661752
• MDR Text Key: 78238458
• Report Number: 2245270-2017-00031
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013871
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/22/2017

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: Nurse
• Device Catalogue Number: CLGY-2034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2017
• Initial Date FDA Received: 06/22/2017
• 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