MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 031-33J

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 04/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The device history record of batch number 74g1801777 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.The dhr shows that the product was assembled and inspected according to specifications.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 impossible to connect the adaptor to the flowmeter, because the screw threads were damaged.Therefore, a new unit was used instead.There was no patient involvement.

Manufacturer Narrative

(b)(4).One (1) unit of 031-33j "nebulizer adaptor 033, sterile , japanese " was received for analysis.During the visual inspection it was observed that there was damage on the screw threads of the adaptor.No other issues were found.Due to the damage on the adaptor, functional testing could not be performed as the sample could not be positioned on the flowmeter.The customer complaint was confirmed based on the visual inspection of the received sample; however, there is not sufficient evidence to assure this issue was originated during the manufacturing process.The complaint description mentions that the product was used by the customer; therefore, the damage could have been caused after its use.The root cause for the condition reported could not be identified.

Event Description

The complaint is reported as: the user found it impossible to connect the adaptor to the flowmeter, because the screw threads were damaged.Therefore, a new unit was used instead.There was no patient involvement.

• 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 Key: 8617155
• MDR Text Key: 145288601
• Report Number: 3004365956-2019-00114
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K153010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/17/2023
• Device Catalogue Number: 031-33J
• Device Lot Number: 74G1801777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Date Manufacturer Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOT REPORTED.; NOT REPORTED.; NOT REPORTED.