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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL NEBULIZER ADAPTOR 028,STERILE,SHELFPAK,; NEBULIZER (DIRECT PATIENT INTE
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TELEFLEX MEDICAL NEBULIZER ADAPTOR 028,STERILE,SHELFPAK,; NEBULIZER (DIRECT PATIENT INTE Back to Search Results
Catalog Number 031-28J
Device Problem Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/30/2018
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.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially relate to this c omplaint.All materials used during the assembly met current specifications.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed due the lack of device sample to perform a proper investigation and determine the root cause.Root cause is unknown.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 "the aquapak bottle and the nebulizer adaptor fell from the flowmeter because the nut adaptor came off the nebulizer adaptor while in use, as a result, a new kit was opened." customer reported there was no patient injury.Patient condition reported as "fine".
 
Event Description
Customer complaint alleges "the aquapak bottle and the nebulizer adaptor fell from the flowmeter because the nut adaptor came off the nebulizer adaptor while in use, as a result, a new kit was opened." customer reported there was no patient injury.Patient condition reported as "fine".
 
Manufacturer Narrative
Qn# (b)(4).The sample was returned for evaluation.The sample was returned for evaluation.A visual exam was performed and signs of use were observed.Functional testing was also performed and the sample passed the tests.During the setup of the oxygen entrainment testing, however, 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 with no functional issues.After the testing was 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 reported complaint was confirmed.Although the condition 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 most likely was caused by the end user during the connection of the adaptor into the flowmeter.However, the personnel of the assembly line were notified on jul-17-2018 for awareness.
 
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Brand Name
NEBULIZER ADAPTOR 028,STERILE,SHELFPAK,
Type of Device
NEBULIZER (DIRECT PATIENT INTE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key7605432
MDR Text Key111179329
Report Number3004365956-2018-00189
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 05/30/2018
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 Date01/14/2022
Device Catalogue Number031-28J
Device Lot Number74A1701640
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2018
Initial Date Manufacturer Received 05/30/2018
Initial Date FDA Received06/15/2018
Supplement Dates Manufacturer Received07/20/2018
Supplement Dates FDA Received07/26/2018
Patient Sequence Number1
Treatment
AQUAPAK BOTTLE; AQUAPAK BOTTLE; AQUAPAK BOTTLE
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