MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON OXYGEN SUPPLY TUBING CONNECTOR; TUBING, PRESSURE AND ACCESSORI

Catalog Number 1420

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted , since the device was not received yet at our facility, and no pictures have been received for evaluation of the alleged defect reported.A device history record review could not be conducted since the lot number was not provided.To perform a proper and thorough investigation to confirm the alleged defect and determine the root cause, it is necessary to evaluate the sample involved.Customer complaint cannot be confirmed based on the information received.Root cause is unknown.No corrective actions can be assigned at this time.If the device sample becomes available at a later date this report will be updated.

Event Description

Customer complaint alleges the device easily disconnects.Alleged issue reported occurred during patient use.No patient injury or consequence was reported.The patient condition was reported as "fine".

• Brand Name: HUDSON OXYGEN SUPPLY TUBING CONNECTOR
• Type of Device: TUBING, PRESSURE AND ACCESSORI
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 7630399
• MDR Text Key: 112196725
• Report Number: 3004365956-2018-00207
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1420
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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