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

Catalog Number 031-33J

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved has not been received by the manufacturer for evaluation at the time of this report.The device history record of batch number 74c1801113 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.Customer complaint cannot be confirmed.The device sample is needed to perform a proper investigation to confirm the allege defect reported, and determine the root cause.Root cause is undetermined.No corrective action can be established at this time.If the sample becomes available this investigation will be updated with the evaluation results.

Event Description

Customer complaint alleges "the user was not able to connect the adaptor to flowmeter; when screwing, the connecting part assembly was not properly connected and fell off.Therefore, a new unit was used instead".(cont.) no patient injury reported.Patient condition reported as fine.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and signs of use were observed.No other issues were found.During the setup of the oxygen entrainment test it was observed that the assembly of the nut adaptor and the upper body component was unstable.The sample failed the testing due to this condition.After the testing was finished, the nut 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.Based on the investigation performed, the reported complaint was confirmed.Although the condition was 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 is most likely caused by the end user during the connection of the adaptor into the flowmeter that causes an unstable connection issue.

Event Description

Customer complaint alleges "the user was not able to connect the adaptor to flowmeter; when screwing, the connecting part assembly was not properly connected and fell off.Therefore, a new unit was used instead".(cont.) no patient injury reported.Patient condition reported as fine.

• 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: 8180918
• MDR Text Key: 131025260
• Report Number: 3004365956-2018-00377
• 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: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/18/2023
• Device Catalogue Number: 031-33J
• Device Lot Number: 74C1801113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLOW METER.; FLOW METER.