MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON TUBING,OXYGEN SUPPLY,7' W/UNIV CONNEC; TUBING, PRESSURE AND ACCESSORI

Catalog Number 1925

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2021

Event Type  malfunction  

Event Description

It was reported "piedmont received variances against catalog hu1925 tubing oxygen 7ft connector standard latex free due to separation from the cannula hose.It appears it doesn't provide a tight connection and will separate from the cannula hose".It was further reported that the "connection of the tubing slipped off with movement of the tubing, as moving when a patient ambulates or moves in the bed".No patient injury or harm reported.Patient condition reported as "fine".

Manufacturer Narrative

Qn# (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.

• Brand Name: HUDSON TUBING,OXYGEN SUPPLY,7' W/UNIV CONNEC
• Type of Device: TUBING, PRESSURE AND ACCESSORI
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 12724138
• MDR Text Key: 280938624
• Report Number: 3004365956-2021-00293
• Device Sequence Number: 1
• Product Code: BYX
• UDI-Device Identifier: 01402670457060
• UDI-Public: 1402670457060
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1925
• Device Lot Number: 74H2100263
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• 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