MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CANNULA,OVER-THE-EAR, W/CC; OXYGEN DELIVERY DEVICE

Catalog Number 1103CC

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

Customer reported "the tubing is kinking at the flow meter and cutting off flow to the pateint".No patient harm reported.

Event Description

Customer reported "the tubing is kinking at the flow meter and cutting off flow to the patient".No patient harm reported.

Manufacturer Narrative

(b)(4).The samples was returned for evaluation.A visual inspection was performed and a tear was observed on the packaging bag.The tape on the packaging bag is sealed correctly.No kinked issues were observed that can lead this customer complaint.Based on the investigation performed, the reported complaint could not be confirmed.No kinked issues were observed.The received sample was found to be within specification.

• Brand Name: HUDSON CANNULA,OVER-THE-EAR, W/CC
• Type of Device: OXYGEN DELIVERY DEVICE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9190945
• MDR Text Key: 194480488
• Report Number: 3004365956-2019-00264
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/10/2023
• Device Catalogue Number: 1103CC
• Device Lot Number: 74J1800494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.