MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CANNULA,OVER-THE-EAR; CANNULA, NASAL, OXYGEN

Catalog Number 1103

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Teleflex has requested additional information regarding the patient condition and the device availability.To date, the customer has not responded.The device has not yet been received for evaluation.However material from the production line was verified and no issues were found that can lead to this customer complaint.Trend analysis for this device family was conducted, and no complaints were received for this same issue for period (b)(6) 2017 to (b)(6) 2018.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed based only on the information provided.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "the device separated, thus there was a desaturation of the patient." no further details were provided.

Event Description

Customer complaint alleges "the device separated, thus there was a desaturation of the patient." no further details were provided.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no separation issues were found.Functional testing was also performed and no issues were encountered.The device history record of lot number 74b1800655 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to our specifications.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.

• Brand Name: HUDSON CANNULA,OVER-THE-EAR
• Type of Device: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7686922
• MDR Text Key: 113955409
• Report Number: 3004365956-2018-00220
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/07/2023
• Device Catalogue Number: 1103
• Device Lot Number: 74B1800655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Date Manufacturer Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1