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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 028,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE
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TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 028,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE Back to Search Results
Catalog Number 031-28J
Device Problems Connection Problem (2900); Separation Problem (4043)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/07/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
The complaint is reported as: "the connection part between the nut adaptor and the flowmeter was so unstable that it got detached during use.Therefore, a new unit was used instead.No harm to the patient occurred".The condition of the patient was reported as "fine".
 
Event Description
The complaint is reported as: "the connection part between the nut adaptor and the flowmeter was so unstable that it got detached during use.Therefore, a new unit was used instead.No harm to the patient occurred".The condition of the patient was reported as "fine".
 
Manufacturer Narrative
(b)(4).The customer complaint description states that the connection part between the nut adaptor and the flowmeter of product code 031-33j (nebulizer adaptor 033,sterile,japanese) was so unstable that it detached during use; however a different sample that is not part of product code 031-33j was received for evaluation.The complaint could not be confirmed as the actual sample was not returned.
 
Manufacturer Narrative
(b)(4).Amended investigation: one (1) unit of 031-28j "nebulizer adaptor 028, sterile, shelfpak," was received for analysis.A visual exam was performed and no defects were observed.Oxygen entrainment testing was performed and during the setup 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 oxygen entrainment testing but the testing failed due to the unstable condition.After the testing finished, the adaptor was carefully disassembled from the upper body and it was visually inspected.During the visual inspection, wear was found on the internal tabs.A device history record review was performed on lot# 74h1900580 and no relevant findings were identified.Based on the investigation performed, the complaint is confirmed.Although the complaint is confirmed, 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.Corrected data: corrected data: section d.1.-brand name corrected to hudson nebulizer adaptor 028 ,sterile,japanese.Section d.4.-product code corrected to 031-28j.Section d.4.-lot #74h1900580.Section d.4.-expiration date corrected to 07-aug-2024.Section h.4.-device manufacture date corrected to 02-aug-2019.
 
Event Description
The complaint is reported as: "the connection part between the nut adaptor and the flowmeter was so unstable that it got detached during use.Therefore, a new unit was used instead.No harm to the patient occurred".The condition of the patient was reported as "fine".
 
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Brand Name
HUDSON NEBULIZER ADAPTOR 028,STERILE,JAPANESE
Type of Device
NEBULIZER (DIRECT PATIENT INTE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key10736254
MDR Text Key213076432
Report Number3004365956-2020-00207
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,Followup
Report Date 10/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number031-28J
Device Lot Number74H1900580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2020
Date Manufacturer Received01/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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