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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 Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Date 05/17/2019
Event Type  malfunction  
Manufacturer Narrative
(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 user found it difficult to connect the adaptor to the flowmeter; it seemed that the screw thread was not easlily fixed because of some defects.Therefore, a new unit was used instead." no patient involvement.
 
Event Description
The complaint is reported as: "the user found it difficult to connect the adaptor to the flowmeter; it seemed that the screw thread was not easlily fixed because of some defects.Therefore, a new unit was used instead." no patient involvement.
 
Manufacturer Narrative
(b)(4).One (1) unit of fg 031-33j "nebulizer adaptor 033,sterile,japanese" was received for analysis.Signs of use are observed since a disinfection tag is present and the sample was not received on its original package.No other issues were found.Sample was tested on oxygen entrainment test (tp-0041 rev.26) and during the setup it was observed that the assembly of the nut adaptor component p/n tfx-001743 and the upper body component p/n mp-0527 was unstable.Even with that condition, the sample was able to be tested on oxygen entrainment testing (tp-0041) but the testing failed due such condition.After the testing finished, the component p/n tfx-001743 was carefully disassembled from the component upper body mp-0527 and it was visually inspected.During the visual inspection it was found wear on its internal tabs.The device history record of batch number 74g1702387 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.See attached dhr records.Based on the additional inspection on the component tfx-001743 of the sample received, the complaint is confirmed.Although the condition observed on the sample provided, there is no sufficient evidence to assure that this issue was originated during the manufacturing assembly or molding process.The wear on the internal tabs of component tfx-001743 most likely be caused by the end user during the connection of the adaptor into the flowmeter that causes an unstable connection issue.Based on previous statements it is not possible to establish a corrective action.
 
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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 Key8684851
MDR Text Key147577415
Report Number3004365956-2019-00139
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 05/21/2019
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 Date07/24/2022
Device Catalogue Number031-33J
Device Lot Number74G1702387
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2019
Initial Date Manufacturer Received 05/21/2019
Initial Date FDA Received06/10/2019
Supplement Dates Manufacturer Received06/28/2019
Supplement Dates FDA Received07/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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