MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON IN-LINE NEB TEE WITH VALVEM; TUBING, PRESSURE & ACCESSORIES

Catalog Number 1743

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges that there is a disconnection issue with the teleflex device and a vyaire product.No report of an injury or impact to the patient.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.A dimensional exam was also performed and the sample was found to be within specification.The returned sample could fit firmly with a nebulizer used at the manufacturing facility.Based on the investigation performed, the reported complaint of "device disconnects from nebulizer" could not be confirmed.There were no issues found with the returned sample.

Event Description

The customer alleges that there is a disconnection issue with the teleflex device and a vyaire product.No report of an injury or impact to the patient.

• Brand Name: HUDSON IN-LINE NEB TEE WITH VALVEM
• Type of Device: TUBING, PRESSURE & ACCESSORIES
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6500656
• MDR Text Key: 73072204
• Report Number: 3011137372-2017-00143
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1743
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2017
• 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
• Treatment: VYAIRE PRODUCT.DRY VENT CIRCUIT.