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

Catalog Number 031-28

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 09/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved has not been received by the manufacturer for evaluation at the time of this report.A device history record review could not be conducted since the lot number provided for this complaint it is not a valid lot number.Customer complaint cannot be confirmed due the lack of device sample to perform a proper investigation and determine the root cause.Root cause is unknown.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges the device threads do not connect.Alleged defect reported as occurred during functional testing prior to a patient use.No patient involvement was reported.

Manufacturer Narrative

(b)(4).One (1) unit of subassembly ph12136 "028 neb adaptor phantom holder" was received for analysis.This subassembly is part of the fg 031-28 "neb adaptor 028, non-sterile, shelfpak" related to this customer complaint.During visual inspection it was observed that the puncture pin protector was missing.It was also observed that the nut adaptor does not spin freely.Sample was tested on oxygen entrainment test 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 such condition.After the testing finished, the component 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 device threads do not connect.Alleged defect reported as occurred during functional testing prior to a patient use.No patient involvement was reported.

• Brand Name: HUDSON NEBULIZER ADAPTOR 028,STERILE,SHELFPAK
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7999357
• MDR Text Key: 124817778
• Report Number: 3004365956-2018-00311
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

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 Catalogue Number: 031-28
• Device Lot Number: 037164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.