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

Catalog Number 1115

Device Problem Material Deformation (2976)

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

Event Date 03/19/2019

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 (dhr) of batch number reported has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.To perform a proper and thorough investigation, it is necessary to evaluate the sample involved.Root cause cannot be determined.Corrective actions cannot be established.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint: "nitric oxide was delivered via nasal cannula.The oxygen tubing was connected from the flowmeter to the nitric module.Oxygen tubing kinked and patient did not receive adequate oxygenation per respiratory therapist".It was reported the patient experienced an o2 desaturation.There was not report of necessary medical intervention.Patient condition reported as fine.

Event Description

Customer complaint: " nitric oxide was delivered via nasal cannula.The oxygen tubing was connected from the flowmeter to the nitric module.Oxygen tubing kinked and patient did not receive adequate oxygenation per respiratory therapist".(continued) it was reported the patient experienced an o2 desaturation.There was not report of necessary medical intervention.Patient condition reported as fine.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and a kink was observed on the tubing; however the sample was not received in its original packaging bag.Functional testing was performed and no issues were encountered during the testing.Based on the investigation performed, the complaint of kinked tubing was confirmed; however, there is not sufficient evidence to assure this issue originated during the manufacturing process.The root cause for the condition reported could not be identified.

• Brand Name: HUDSON TUBING, OXYGEN SUPPLY 7'
• Type of Device: TUBING, PRESSURE AND ACCESSORI
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8449012
• MDR Text Key: 139735990
• Report Number: 3004365956-2019-00084
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1115
• Device Lot Number: 74K1801458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Date Manufacturer Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NITRIC OXIDE. NITRIC MODULE. FLOWMETER.; NITRIC OXIDE. NITRIC MODULE. FLOWMETER.; NITRIC OXIDE. NITRIC MODULE. FLOWMETER.