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

Catalog Number 1115

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); Low Oxygen Saturation (2477)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

Qn#: (b)(4).Uf/importer report# (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.

Event Description

Medwatch complaint received: "went in to check on patient with another nurse and after repositioning pt, checked the oxygen tubing.The part where the two ends connect to make one tube was pulled out on one side.Switched oxygen tubing and checked oxygen.Level was at 77%.After switching tubing, her o2 came back up to 94-96%." additional information was received and it was reported there was no harm to the patient.Oxygen saturation dropped to 77%, but quickly recovered once the tubing was changed out.

• Brand Name: HUDSON TUBING, OXYGEN SUPPLY 7'
• 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: victoria sandlin ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 10713233
• MDR Text Key: 212347701
• Report Number: 3004365956-2020-00208
• 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: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1115
• Device Lot Number: 74K1901650
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2019
• 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: NONE REPORTED.
• Patient Outcome(s): Other