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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE
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TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE Back to Search Results
Catalog Number 031-33J
Device Problem Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Date 11/28/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer complaint alleges "the user was not able to connect the adaptor to the flowmeter because the connecting part assembly was so unstable.Therefore, a new unit was opened instead." no patient involvement was reported.
 
Event Description
Customer complaint alleges "the user was not able to connect the adaptor to the flowmeter because the connecting part assembly was so unstable.Therefore, a new unit was opened instead." no patient involvement was reported.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and signs of use were observed.No other issues were found.During the setup of the oxygen entrainment test it was observed that the assembly of the nut adaptor and the upper body component was unstable.Even with that condition, the sample was able to be tested on the oxygen entrainment testing with satisfactory results.After the testing was finished, the adaptor was carefully disassembled from the upper body and was visually inspected.During the visual inspection it was found there was wear on the internal tabs.A device history record review was performed and there were no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated or the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.Based on the investigation performed, the reported complaint was confirmed.Although the condition was observed on the sample provided, there is not sufficient evidence to assure that this issue was originated during the manufacturing assembly or molding process.The wear on the internal tabs of the adaptor was most likely caused by the end user during the connection of the adaptor into the flowmeter that causes an unstable connection issue.
 
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Brand Name
HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
Type of Device
NEBULIZER (DIRECT PATIENT INTE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8173284
MDR Text Key130624484
Report Number3004365956-2018-00357
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
PMA/PMN Number
K153010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date11/18/2021
Device Catalogue Number031-33J
Device Lot Number74L1602022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2019
Initial Date Manufacturer Received 11/28/2018
Initial Date FDA Received12/18/2018
Supplement Dates Manufacturer Received01/18/2019
Supplement Dates FDA Received01/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FLOW METER.; FLOW METER.; FLOW METER
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