MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON TRACH ADAPTOR; AIRWAY CONNECTOR

Catalog Number 2415-01

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The customer alleges that the tubing is disconnecting from the adaptor.No patient injury or harm reported.

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The sample was returned for evaluation.A visual exam was performed and it was observed that the tube was disconnected and the tubing was damaged.The dimensions of the tube and adapter were measured and were found to be within specification.In the current manufacturing procedure, a 100% visual inspection is conducted after the assembly process; therefore, a defect of this type would be detected prior to release.Based on the investigation performed, it was determined that the detached tubing was most likely caused by mishandling of the product during usage.

Event Description

The customer alleges that the tubing is disconnecting from the adaptor.No patient injury or harm reported.

• Brand Name: HUDSON TRACH ADAPTOR
• Type of Device: AIRWAY CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5813825
• MDR Text Key: 51011665
• Report Number: 8040412-2016-00150
• Device Sequence Number: 1
• Product Code: BZA
• 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,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/12/2020
• Device Catalogue Number: 2415-01
• Device Lot Number: 201551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2016
• 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