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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MASK,MEDIUM CONC,ELONG,PED; MASK, OXYGEN
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TELEFLEX MEDICAL HUDSON MASK,MEDIUM CONC,ELONG,PED; MASK, OXYGEN Back to Search Results
Catalog Number 1042
Device Problem Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided at the time of this report.The device history record of batch number reported has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.To perform a proper investigation, and determine the source of alleged defect reported, it is necessary to evaluate the sample involved.Customer complaint cannot be confirmed.Root cause is unknown.No corrective actions can be assigned.If the device sample becomes available this report will be updated with the evaluation results.
 
Event Description
Customer complaint alleges device "tubing coming apart at the mask connection".Alleged malfunction reported occurred during use.No patient injury or consequence reported.Patient condition reported as "fine".
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the female adaptor is easily disconnected from the grommet.The female adaptor tubing was measured and was found to be within dimensional specifications.Based on the investigation performed the complaint was confirmed.Although the complaint was confirmed, there is not sufficient evidence to assure this issue was originated during the manufacturing process.A dimensional inspection was performed and no dimensional issues were found.However due to customer complaint trending a capa request was initiated in order to further investigate this issue.
 
Event Description
Customer complaint alleges device "tubing coming apart at the mask connection".Alleged malfunction reported occurred during use.No patient injury or consequence reported.Patient condition reported as "fine".
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the female adaptor is easily disconnected from the grommet.The female adaptor tubing was measured and was found to be within dimensional specifications.Based on the investigation performed the complaint was confirmed.Although the complaint was confirmed, there is not sufficient evidence to assure this issue was originated during the manufacturing process.A dimensional inspection was performed and no dimensional issues were found.However due to customer complaint trending a capa request was initiated in order to further investigate this issue.
 
Event Description
Customer complaint alleges device "tubing coming apart at the mask connection".Alleged malfunction reported occurred during use.No patient injury or consequence reported.Patient condition reported as "fine".
 
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Brand Name
HUDSON MASK,MEDIUM CONC,ELONG,PED
Type of Device
MASK, OXYGEN
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key7952409
MDR Text Key123265387
Report Number3004365956-2018-00283
Device Sequence Number1
Product Code BYG
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 09/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number1042
Device Lot Number74G1800724
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2018
Date Manufacturer Received10/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
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