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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE
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TELEFLEX HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE Back to Search Results
Catalog Number 031-33J
Device Problems Unsealed Device Packaging (1444); Packaging Problem (3007)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2014
Event Type  malfunction  
Event Description
The event is reported as: during incoming inspection by the (b)(4), a faulty seal was noted on the package.A total of two devices were reported with this issue.
 
Manufacturer Narrative
Picture received with the customer complaint file was carefully reviewed.The sample presented an open seal.This type of defect is easy to be defected during the manufacturing of the product since is verified at 100%.Additionally, per internal procedure, distribution center performs 100% inspection as well.Based on the picture provided, customer complaint is confirmed.Manufacturing and r&d departments are evaluating the current packaging design, a proposal of a new packaging material has been identified, therefore a process/design validation has been initiated.The involved production and quality personnel were informed about this complaint.
 
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Brand Name
HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE
Type of Device
NEBULIZER ADAPTOR
Manufacturer (Section D)
TELEFLEX
rtp NC
Manufacturer Contact
margie burton, rn
p.o. box 12600
durham, NC 27709
9194334965
MDR Report Key4114968
MDR Text Key4938913
Report Number3004365956-2014-00344
Device Sequence Number1
Product Code CCQ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 08/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number031-33J
Device Lot Number02A1403282
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received08/25/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2014
Is the Device Single Use? Yes
Patient Sequence Number1
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