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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 Gas/Air Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/31/2018
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 received by the manufacturer at the time of this report.A device history record review shows that the device was assembled and inspected according to our specifications.No issues or discrepancies were found which could potentially relate to this complaint.Customer complaint cannot be confirmed due the lack of device sample to perform a proper investigation and determine the root cause.No corrective actions can be assigned at this time.If the sample becomes available this report will be updated with the evaluation results.
 
Event Description
Customer complaint alleges "it was reported that oxygen was leaked from flowmeter adaptor.Therefore, a new unit was used instead." alleged issue reported as occurred during use.It was reported there was no patient injury.(cont.) patient condition reported as "fine".
 
Manufacturer Narrative
(b)(4).One (1) unit of subassembly ph12153 033 neb adaptor phantom holder was received for analysis.This subassembly is part of the 031-33j nebulizer adaptor 033, sterile, japanese, related to this customer complaint.Signs of use are observed, and the sample was received without the puncture pin protector.Also, during the visual inspection it was observed that component adaptor doesn't spin freely and the tubing was loose from the nebulizer base.The sample was tested on the dual station lift test and general pull and push test procedures with no functional issues.However, 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 oxygen entrainment testing but the testing failed.After the testing finished, the adaptor was carefully disassembled from the upper body and it was visually inspected.During the visual inspection it was found there was wear on the internal tabs.Attempts to duplicate the failure mode were performed and there are two ways to duplicate them: the first one is by overtightening the nut adaptor into the flow meter.The second one is by manipulating the assembly connection.Based on the investigation performed the complaint is 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.However, the personnel of the assembly line were notified on oct-16-2018 for awareness.
 
Event Description
Customer complaint alleges "it was reported that oxygen was leaked from flowmeter adaptor.Therefore, a new unit was used instead." alleged issue reported as occurred during use.It was reported there was no patient injury.(cont.) patient condition reported as "fine".
 
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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 Key7882325
MDR Text Key120534648
Report Number3004365956-2018-00270
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 08/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date08/08/2022
Device Catalogue Number031-33J
Device Lot Number74H1700251
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2018
Date Manufacturer Received10/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
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