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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUDSON ADAPTOR,CUFF,22MM ID; CONNECTOR, AIRWAY (EXTENSION)
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HUDSON ADAPTOR,CUFF,22MM ID; CONNECTOR, AIRWAY (EXTENSION) Back to Search Results
Catalog Number 1421
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/02/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Two pictures of catalog number 1421 (adaptor, cuff, 22mm id) were received for analysis.It can be observed the adaptor in its original packaging sealed, one photo shows the side of the label with the lot number reported and the other photo shows the clear part where the adaptor can be observed, and no broken issues were noted.Also, in both photos can be observed a piece of plastic outside of sample package.A device history record review was performed and no relevant findings were identified.Customer complaint cannot be confirmed since the reported damage were not observed on the sample showed on the received pictures.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
The complaint is reported as: "the part that broke is a connector that sits between the ventilator circuit and the patient's flex tube.The patient is a resident at a long term care facility and is on a ventilator full time.The connector broke while the patient was being transported off site.The staff were able to occlude the hole in the circuit and take the patient back into the hospital where they changed the broken connector.There was no compromise to the patient's ventilation during this event." customer reported since using the device they are "noticing that it requires a change every 2-3 days, as they are noticing cracks".
 
Manufacturer Narrative
(b)(4).One piece of plastic belonging to product code 1421 was received for analysis.The plastic piece was received in a bag and was not received in the original packaging.A functional inspection could not be performed as the whole sample was not returned, only a piece of the plastic.A device history record review was performed and no relevant findings were identified.Based on the visual exam of the returned piece of plastic from the adaptor, the complaint is confirmed.Although the complaint is co nfirmed, there is not enough evidence to assure that this issue was originated during the manufacturing assembly or molding process.The damage on the adaptor could be caused by the end user during the connection of the adaptor into the device, although this could not be confirmed.The complete device sample is needed to perform a proper investigation and determine a true root cause.
 
Event Description
The complaint is reported as: "the part that broke is a connector that sits between the ventilator circuit and the patient's flex tube.The patient is a resident at a long term care facility and is on a ventilator full time.The connector broke while the patient was being transported off site.The staff were able to occlude the hole in the circuit and take the patient back into the hospital where they changed the broken connector.There was no compromise to the patient's ventilation during this event." customer reported since using the device they are "noticing that it requires a change every 2-3 days, as they are noticing cracks".
 
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Brand Name
HUDSON ADAPTOR,CUFF,22MM ID
Type of Device
CONNECTOR, AIRWAY (EXTENSION)
MDR Report Key10755702
MDR Text Key213679749
Report Number3004365956-2020-00215
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 distributor,foreign,user faci
Type of Report Initial,Followup
Report Date 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number1421
Device Lot Number74E2001618
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2020
Date Manufacturer Received12/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
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