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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON TUBING,STAR LUMEN,25'; OXYGEN SUPPLY TUBING
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TELEFLEX MEDICAL HUDSON TUBING,STAR LUMEN,25'; OXYGEN SUPPLY TUBING Back to Search Results
Catalog Number 1119
Device Problems Coiled (1098); Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/22/2015
Event Type  malfunction  
Event Description
The customer alleges that the tubing rolled under the bed and the customer's oxygen level de-saturated.Once the kinking/coiling was located the patient's saturation level increased.No report of patient harm.
 
Manufacturer Narrative
(b)(4).The investigation is incomplete at the time of this report.
 
Manufacturer Narrative
(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.A visual inspection of the product involved in the complaint could not be conducted as the sample was not returned and a photo of the defect was not provided.Current inventory of component part number tfx-000180-05 tubing star lumen frosted 25' lot numbers 4-2315741 & 4-2315742 (that is part of the catalog number 1119 tubing, star lumen, 25') were inspected and no issues were found that could lead to the condition reported by the customer.Functional testing was also performed on the samples and no issues were found.The reported complaint could not be confirmed as no sample was returned for evaluation.If the sample is returned, a follow-up report will be submitted with investigation results.
 
Event Description
The customer alleges that the tubing rolled under the bed and the customer's oxygen level de-saturated.Once the kinking/coiling was located the patient's saturation level increased.No report of patient harm.
 
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Brand Name
HUDSON TUBING,STAR LUMEN,25'
Type of Device
OXYGEN SUPPLY TUBING
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo 8827 5
MX   88275
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key4844135
MDR Text Key21082381
Report Number3004365956-2015-00164
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Respiratory Therapist
Type of Report Initial,Followup
Report Date 05/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/23/2020
Device Catalogue Number1119
Device Lot Number74C1502679
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/18/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/18/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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