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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MASK,MEDIUM CONC,ADULT; MASK, OXYGEN
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TELEFLEX MEDICAL HUDSON MASK,MEDIUM CONC,ADULT; MASK, OXYGEN Back to Search Results
Catalog Number 1040
Device Problem Disconnection (1171)
Patient Problem No Patient Involvement (2645)
Event Date 01/11/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved has not been received by the manufacturer for evaluation at the time of this report.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.The dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.To perform a proper and thorough investigation, to confirm the complaint and determine a root cause, it is necessary to evaluate the sample involved.If the sample becomes available this report will be updated with the evaluation results.
 
Event Description
Customer complaint alleges "the oxygen tube and the adaptor was easily disconnected before use.Therefore, a new package was used instead." alleged issue reported as occurred prior to patient use.No patient involvement was reported.
 
Event Description
Customer complaint alleges "the oxygen tube and the adaptor was easily disconnected before use.Therefore, a new package was used instead." alleged issue reported as occurred prior to patient use.No patient involvement was reported.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the female adaptor was received well connected to the grommet.The grommet and the female adaptor tubing were found within dimensional specifications.A pull test inspection was performed and the customer complaint was confirmed as during the testing it was observed that the female adaptor easily disconnects from the grommet.Based on the investigation performed, the reported complaint was confirmed.A capa was opened to further investigate this issue.
 
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Brand Name
HUDSON MASK,MEDIUM CONC,ADULT
Type of Device
MASK, OXYGEN
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8270804
MDR Text Key133860602
Report Number3004365956-2019-00019
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,foreig
Type of Report Initial,Followup
Report Date 01/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number1040
Device Lot Number74F1801261
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2019
Date Manufacturer Received02/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
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