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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL MASK,HIGH CONCEN,BOTTOM INLET, PURITAN; MASK, OXYGEN
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TELEFLEX MEDICAL MASK,HIGH CONCEN,BOTTOM INLET, PURITAN; MASK, OXYGEN Back to Search Results
Catalog Number 7638
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 10/01/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).At this time, it is unknown if the device is available for evaluation by the manufacturer.Teleflex has requested this information.From visual inspection of a picture provided by the customer, an incorrect assembly can be observed on the green tape of this product.A visual, dimensional and functional inspection of the physical device involved in the complaint could not be conducted since the device was not returned at the time of this report.A device history record review could not be conducted since the lot number was not provided.Customer complaint (an integrity issue at the joint between the bag and the tube for the masks causes a leak) cannot be confirmed based only on the information provided.From a picture provided by the customer, and an incorrect assembly can be observed.However it is was not possible to confirm if the incorrect assembly was performed during the manufacturing process at teleflex (b)(4).To perform a proper and through investigation, it is necessary to evaluate the sample involved in this complaint.If the sample becomes available this report will be updated with the evaluation results.
 
Event Description
Customer complaint alleges an integrity issue at the joint between the bag and the tube for the masks causes a leak.Alleged issue reported as detected during testing.There was no report of patient or consumer involvement.
 
Manufacturer Narrative
(b)(4).The initial mdr sent on 14 december 2017 was submitted in error.It has been determined that this is not a reportable event.
 
Event Description
Customer complaint alleges an integrity issue at the joint between the bag and the tube for the masks causes a leak.Alleged issue reported as detected during testing.There was no report of patient or consumer involvement.
 
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Brand Name
MASK,HIGH CONCEN,BOTTOM INLET, PURITAN
Type of Device
MASK, OXYGEN
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo 88275
MX   88275
Manufacturer Contact
linda woodall
3015 carrington mill blvd
morrisville 27560
9196942566
MDR Report Key7117006
MDR Text Key94839343
Report Number3004365956-2017-00426
Device Sequence Number1
Product Code BYG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number7638
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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