MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEB ADAPTOR 028, NON-STERILE, SHELFPAK; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 031-28

Device Problems Break (1069); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Complaint reported as: "the adapter breaks when threading in the flowmeter, if the product is not threaded to the end, it leaks, if it is threaded to the end, the adapter breaks." no patient harm reported.

Event Description

Complaint reported as: "the adapter breaks when threading in the flowmeter, if the product is not threaded to the end, it leaks, if it is threaded to the end, the adapter breaks." no patient harm reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the adaptor doesn't spin freely, probably due to an incorrect use of the device when threading the adapter in the flowmeter.It is reported in the complaint that "the adapter breaks when threading in the flowmeter, if the product is not threaded to the end, it leaks, if it is threaded to the end, the adapter breaks." no other issues were found.Oxygen entrainment testing was performed and during the setup it was observed that the assembly of the nut adaptor and the upper body was unstable.Even with that condition, the sample was able to be tested on oxygen entrainment testing but the testing failed due to the unstable condition.After the testing finished, the adaptor was carefully disassembled from the upper body and it was visually inspected.During the visual inspection it was observed there was wear on the internal tabs.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the complaint is confirmed.Although the complaint is confirmed, 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.

• Brand Name: HUDSON NEB ADAPTOR 028, NON-STERILE, SHELFPAK
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9552619
• MDR Text Key: 196231032
• Report Number: 3004365956-2020-00007
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K141214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 031-28
• Device Lot Number: 74L1801263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.