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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ADAPTOR,028 NEB,INTL; NEBULIZER (DIRECT PATIENT INTE

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TELEFLEX MEDICAL HUDSON ADAPTOR,028 NEB,INTL; NEBULIZER (DIRECT PATIENT INTE Back to Search Results
Catalog Number 403128
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/29/2018
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.However as an additional test, visual inspection was performed to 42 production samples of code (b)(4), batch 74k1801098 that were taken randomly from assembly line.During the inspection no issues or discrepancies were found than can lead to the condition reported by the customer.The device history record was reviewed and no issues or discrepancies were found which could potentially relate to this complaint.It is necessary to have the physical sample in order to perform a proper investigation to confirm the alleged defect and determine a root cause.Customer complaint cannot be confirmed.Root cause is unknown.If the sample becomes available this report will be updated with the evaluation results.
 
Event Description
Customer complaint alleges "it was found before using it to the patient.Material was leaking at the dose meter." no patient impact or consequence was reported.Patient condition reported as fine.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and signs of use were observed.It was also noticed that there was damage on the thread of the nut adaptor and the puncture pin protector was missing.During the setup of the oxygen entrainment test it was observed that the assembly of the nut adaptor and the upper body was unstable.Even with that condition, the sample was able to be tested on the oxygen entrainment testing but the testing failed.Based on the functional inspection results of the sample received, 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 damage found on the thread of the adaptor most likely is caused by the end user during the connection of the adaptor into the flowmeter that causes an unstable connection issue.
 
Event Description
Customer complaint alleges "it was found before using it to the patient.Material was leaking at the dose meter." no patient impact or consequence was reported.Patient condition reported as fine.
 
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Brand Name
HUDSON ADAPTOR,028 NEB,INTL
Type of Device
NEBULIZER (DIRECT PATIENT INTE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8020650
MDR Text Key126250598
Report Number3004365956-2018-00322
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 distributor,foreign,user faci
Type of Report Initial,Followup
Report Date 10/15/2018
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 Catalogue Number403128
Device Lot Number74J1701880
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2018
Initial Date Manufacturer Received 10/15/2018
Initial Date FDA Received10/30/2018
Supplement Dates Manufacturer Received12/12/2018
Supplement Dates FDA Received12/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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