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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEB ADAPTOR 028, NON-STERILE, SHELFPAK; NEBULIZER (DIRECT PATIENT INTE
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TELEFLEX MEDICAL HUDSON NEB ADAPTOR 028, NON-STERILE, SHELFPAK; NEBULIZER (DIRECT PATIENT INTE Back to Search Results
Catalog Number 031-28
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2020
Event Type  malfunction  
Manufacturer Narrative
(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
Customer reported the device is "spitting out water" and leaks water everywhere during patient use.No patient harm was reported.
 
Event Description
Customer reported the device is "spitting out water" and leaks water everywhere during patient use.No patient harm was reported.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
HUDSON NEB ADAPTOR 028, NON-STERILE, SHELFPAK
Type of Device
NEBULIZER (DIRECT PATIENT INTE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key10150539
MDR Text Key195031752
Report Number3004365956-2020-00120
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
PMA/PMN Number
K141214
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 06/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number031-28
Device Lot Number74G1903110
Was Device Available for Evaluation? No
Date Manufacturer Received06/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
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