MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MASK,MEDIUM CONC,ELONG,ADULT; MASK, OXYGEN

Catalog Number 1041

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved has not been received by the manufacturer for evaluation at the time of this report.However material from the production line was verified and no issues were found that can lead this customer complaint.The device history record of the batch number reported has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.Customer complaint cannot be confirmed based only on the information provided.To perform a proper investigation and determine the source of the alleged defect reported, it is necessary to evaluate the sample involved.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges the tubing falls off the oxygen mask during use.Customer reports "no delay or affect to patient care" due to this issue.Patient condition reported as fine.

Manufacturer Narrative

Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and no issues were observed.The sample was assembled correctly.The female adaptor tubing and grommet were measured and found to be within dimensional specifications.Based on the investigation performed the complaint could not be confirmed.There were no issues found with the returned device.

Event Description

Customer complaint alleges the tubing falls off the oxygen mask during use.Customer reports "no delay or affect to patient care" due to this issue.Patient condition reported as fine.

• Brand Name: HUDSON MASK,MEDIUM CONC,ELONG,ADULT
• Type of Device: MASK, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7984906
• MDR Text Key: 125632186
• Report Number: 3004365956-2018-00317
• Device Sequence Number: 1
• Product Code: BYG
• 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: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1041
• Device Lot Number: 74G1801667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.