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

Catalog Number 031-33J

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No dhr review was performed since the lot number provided by the customer is not associated with any product manufactured at arlington heights facility.Teleflex has requested clarification.The device has not been received for evaluation by the manufacturer at the time of this initial report.Customer complaint cannot be confirmed.Root cause is unknown.If the device becomes available this report will be updated accordingly.

Event Description

Customer complaint alleges device "was not properly nebulized while in use.Therefore, it was replaced with a new unit".Alleged issue reported as detected during a patient use.No patient harm reported.Patient condition reported as fine.

Event Description

Customer complaint alleges device "was not properly nebulized while in use.Therefore, it was replaced with a new unit".Alleged issue reported as detected during a patient use.No patient harm reported.Patient condition reported as fine.

Manufacturer Narrative

Qn#(b)(4).Brand name corrected to hudson nebulizer adaptor 033 ,sterile,japanese.Common device name corrected to nebulizer (direct patient interface).Procode corrected to caf.Catalog# corrected to 031-33j.The sample was returned for evaluation.A visual exam was performed and it was observed that there was a discoloration of the pin inside the adaptor.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 with satisfactory results.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.A device history record review was performed 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.The dhr shows that the product was assembled and inspected according to specifications.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 device "was not properly nebulized while in use.Therefore, it was replaced with a new unit".Alleged issue reported as detected during a patient use.No patient harm reported.Patient condition reported as fine.

Manufacturer Narrative

Qn#(b)(4).Brand name corrected to hudson nebulizer adaptor 033 ,sterile,japanese.Common device name corrected to nebulizer (direct patient interface).Procode corrected to caf.Catalog# corrected to 031-33j.The sample was returned for evaluation.A visual exam was performed and it was observed that there was a discoloration of the pin inside the adaptor.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 with satisfactory results.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.A device history record review was performed 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.The dhr shows that the product was assembled and inspected according to specifications.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.

• 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: 8159919
• MDR Text Key: 130329841
• Report Number: 1417411-2018-00084
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• 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: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/18/2023
• Device Catalogue Number: 031-33J
• Device Lot Number: 74C1801113
• 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: NONE REPORTED.; NONE REPORTED.