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

Catalog Number 031-33J

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record (dhr) of batch number 74a1800860 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.Dhr shows that the product was assembled and inspected according to our specifications.A follow up report will be submitted at the conclusion of the device evaluation.

Event Description

Customer complaint alleges "that during test, the snap-on connector was detached from the nebulizer adaptor by the weight of the aquapak." no patient involvement reported.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.During the visual inspection it was observed that the sample was not received in its original package.No defects 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.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 "that during test, the snap-on connector was detached from the nebulizer adaptor by the weight of the aquapak." no patient involvement 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: 8124391
• MDR Text Key: 129038006
• Report Number: 3004365956-2018-00344
• 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: 11/08/2018

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: 01/09/2023
• Device Catalogue Number: 031-33J
• Device Lot Number: 74A1800860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 01/08/2019
• Supplement Dates FDA Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AQUAPAK (NO FURTHER DETAILS); AQUAPAK (NO FURTHER DETAILS); AQUAPAK (NO FURTHER DETAILS)