MAUDE Adverse Event Report: TELEFLEX MEDICAL TUBING, OXYGEN SUPPLY 7', W/CC; OXYGEN DELIVERY DEVICE

Catalog Number 1115CC

Device Problems Complete Blockage (1094); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

Customer is complaining that the tubing is too playable and is becoming kinked.The customer reports that this issue did not allow oxygen flow.No infant injury or consequence.

Event Description

Customer is complaining that the tubing is too plyable and is becoming kinked.The customer reports that this issue did not allow oxygen flow.No infant injury or consequence.

Manufacturer Narrative

(b)(4).The actual sample was not returned; however, the customer did return an unopened representative sample.A visual exam was performed and no kinking was observed.The sample was then tested on supply tubing and connector test with no functional issues found.The device history record of batch number 74j1801844 that belong to catalog number 1115cc has been reviewed and no issues or discrepancies were found which could potentially be related 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 specifications.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned representative sample.The actual device was not returned.

• Brand Name: TUBING, OXYGEN SUPPLY 7', W/CC
• Type of Device: OXYGEN DELIVERY DEVICE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8684658
• MDR Text Key: 147516016
• Report Number: 3004365956-2019-00151
• Device Sequence Number: 1
• Product Code: BYX
• 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: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/20/2023
• Device Catalogue Number: 1115CC
• Device Lot Number: 74J1801844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Date Manufacturer Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1