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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ADAPTOR,PRESSURE LINE; CONNECTOR, AIRWAY (EXTENSION)
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TELEFLEX MEDICAL HUDSON ADAPTOR,PRESSURE LINE; CONNECTOR, AIRWAY (EXTENSION) Back to Search Results
Catalog Number 1642
Device Problem Gas/Air Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/07/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: or setting (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on potential lot numbers 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
Customer reported the adaptor leaked during use.The adaptor was placed inline on the inspiratory limb of the ventilator circuit.The respiratory therapist noticed a volume loss on the set tidal volume delivery and heard a leak on the adaptor coming from the protruding elbow connection.It was reported the adaptor was replaced and that solved the problem.No patient harm reported.
 
Event Description
Customer reported the adaptor leaked during use.The adaptor was placed inline on the inspiratory limb of the ventilator circuit.The respiratory therapist noticed a volume loss on the set tidal volume delivery and heard a leak on the adaptor coming from the protruding elbow connection.It was reported the adaptor was replaced and that solved the problem.No patient harm reported.
 
Manufacturer Narrative
Continuation of d11: or setting.Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Leak testing was also performed and no issues were found.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.
 
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Brand Name
HUDSON ADAPTOR,PRESSURE LINE
Type of Device
CONNECTOR, AIRWAY (EXTENSION)
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9611449
MDR Text Key194826009
Report Number3004365956-2020-00013
Device Sequence Number1
Product Code BZA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 01/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number1642
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2020
Date Manufacturer Received02/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PURITAN BENNET VENTILATOR - HIGH-PRESSURE VENTILAT; PURITAN BENNET VENTILATOR - HIGH-PRESSURE VENTILAT
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