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 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved has not been received for evaluation by the manufacturer at the time of this report.The device history record (dhr) of batch number 74j1701929 has been reviewed.No issues or discrepancies were found which could potentially relate to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed.Root cause cannot be determined.No corrective actions can be assigned.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges the connection between the adaptor and the flow meter was unstable.A new device was obtained for use.No patient involvement was reported.

Manufacturer Narrative

(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 connection between the adaptor and the flowmeter was unstable.A new device was obtained for use.No patient involvement was reported.

• 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: 8174807
• MDR Text Key: 130822061
• Report Number: 3004365956-2018-00370
• 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: 12/06/2018

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 Date: 09/18/2022
• Device Catalogue Number: 031-33J
• Device Lot Number: 74J1701929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 02/01/2019
• Supplement Dates FDA Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLOW METER.; FLOW METER.