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

Catalog Number 031-33J

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved has not been received for investigation by the manufacturer at the time of this report.The device history record of batch number 74m1701663 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.Customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and determine the root cause.No root cause can 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 part of the assembly to the flowmeter came off.A new unit was obtained for use.It was reported there was no patient involvement.

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 stable.The sample passed the testing.Based on the investigation performed, the reported complaint could not be confirmed.The sample was found to be within functional specifications and no issues were found during testing.

Event Description

Customer complaint alleges the connection part of the assembly to the flowmeter came off.A new unit was obtained for use.It was reported there was no patient involvement.

• Brand Name: HUDSIN NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8169354
• MDR Text Key: 130500761
• Report Number: 3004365956-2018-00363
• 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: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/14/2022
• Device Catalogue Number: 031-33J
• Device Lot Number: 74M1701663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Date Manufacturer Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLOW METER.; FLOW METER.; FLOW METER