Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TELEFLEX MEDICAL NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE Back to Search Results
Catalog Number 031-33J
Device Problems Disconnection (1171); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/07/2017
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 provided at the time of this report.A device history record investigation shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based on the information received.It is necessary to have the device sample to perform a proper investigation to confirm the alleged defect, and determine the root cause.If the device sample becomes available at a later date , this report will be updated with the evaluation results.
 
Event Description
Customer complaint alleges "the connection part assembly to the flowmeter came off the nebulizer adapter during use on a patient.Therefore, a new unit was used instead".The customer reports there was no harm to the patient.The patient's condition was reported as "fine".
 
Manufacturer Narrative
(b)(4).The sample was received for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and no issues were found.It was noticed, however, that during the oxygen entrainment test the assembly of the nut adaptor and the upper body was unstable.Even with that condition, the testing was able to be performed, but the sample failed the test.After the sample failed, the nut adaptor was carefully disassembled from the upper body and it was visually inspected.It was observed that there was wear on the internal locks.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.The complaint is confirmed based on the investigation performed.Although the complaint was 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 thread of adaptor is most likely caused by the end user during the connection of the adaptor into the flowmeter that causes an unstable connection.Personnel from adaptor assembly line were notified for awareness.
 
Event Description
Customer complaint alleges "the connection part assembly to the flowmeter came off the nebulizer adapter during use on a patient.Therefore, a new unit was used instead".The customer reports there was no harm to the patient.The patient's condition was reported as "fine".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NEBULIZER ADAPTOR 033,STERILE,JAPANESE
Type of Device
NEBULIZER (DIRECT PATIENT INTE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo 88275
MX   88275
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6753698
MDR Text Key81385653
Report Number3004365956-2017-00311
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K153010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/24/2017
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 Date11/03/2021
Device Catalogue Number031-33J
Device Lot Number74L1600507
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/24/2017
Initial Date FDA Received07/31/2017
Supplement Dates Manufacturer Received10/02/2017
Supplement Dates FDA Received10/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-