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

Catalog Number 1115

Device Problems Leak/Splash (1354); Improper Flow or Infusion (2954)

Patient Problems Low Oxygen Saturation (2477); No Code Available (3191)

Event Date 01/08/2017

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The patient was reported to have been placed back on (the) ventilator for 1.5 hours.Patient reported to have recovered to baseline.By report the patient had no serious injury.Additional potential lot# reported 74k19000710.A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report.There was no photo for review.Two potential lot numbers were given in the complaint.A device history record review for each lot number provided shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.In order to perform a proper investigation and determine the source of the alleged defect reported it is necessary to evaluate the device involved in this complaint.If the device becomes available at a later date, this investigation will be updated with the evaluation results.

Event Description

Customer complaint alleges "leaking at connector.Insufficient o2 being delivered to patient.Spo2 down to 80s, the patient had to be placed back on ventilator for 1.5 hours.The patient recovered to their previous baseline.".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and the sample passed the leak test.No issues were detected.Based on the investigation performed, the reported complaint could not be confirmed.The product was assembled and inspected according to specifications, and there were no issued found during the visual exam and functional testing.The product functioned as intended.

Event Description

Customer complaint alleges "leaking at connector.Insufficient o2 being delivered to patient.Spo2 down to 80's, the patient had to be placed back on ventilator for 1.5 hours.The patient recovered to their previous baseline.".

• Brand Name: HUDSON TUBING, OXYGEN SUPPLY 7'
• Type of Device: PRESSURE TUBING AND ACCESSORIES
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6271072
• MDR Text Key: 65530103
• Report Number: 3004365956-2017-00048
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/15/2021
• Device Catalogue Number: 1115
• Device Lot Number: 74G1601531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2016
• 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
• Treatment: OXYGEN CONNECTOR