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 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved or a picture of the alleged defect, was not received for evaluation by the manufacturer at the time of this report.The device history record of the lot number reported has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.It is necessary to have the physical sample in order to perform a proper investigation to confirm the alleged defect and determine a root cause.Customer complaint cannot be confirmed.Root cause is unknown.No corrective action can be assigned at this time.If the device becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "the connector of the nebulizer adaptor detached from the adaptor while in use so the aquapak fell on the floor." alleged issue reported occurred during use.No patient injury was reported.Patient condition reported as fine.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and signs of use were observed.It was also found that the nut adaptor did not spin freely.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.Even with that condition, the sample was able to be tested on the oxygen entrainment testing but the testing failed.After the testing was finished, the adaptor was carefully disassembled from the upper body and 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 was 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 connector of the nebulizer adaptor detached from the adaptor while in use so the aquapak fell on the floor." alleged issue reported occurred during use.No patient injury was 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: 8015451
• MDR Text Key: 125449123
• Report Number: 3004365956-2018-00324
• 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: 10/19/2018

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: 11/10/2021
• Device Catalogue Number: 031-33J
• Device Lot Number: 74L1601445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 10/29/2018
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 12/06/2018
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.