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

Catalog Number 031-33J

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been received by the manufacturer for evaluation 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.Customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and determine the root cause.Root cause is unknown.No corrective actions can be assigned at this time.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "the user was not able to connect the adaptor to flowmeter; when screwing, the connecting part assembly was not properly connected and fell off.Therefore, a new unit was used instead." no patient injury reported.(cont.) 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.The sample was tested on the dual station lift test and general pull and push test procedures with no functional issues.However, 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.Attempts to duplicate the failure mode were performed and there are two ways to duplicate them: the first one is by overtightening the nut adaptor into the flow meter.The second one is by manipulating the assembly connection.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.Personnel of the assembly line were notified on (b)(6) 2018 for awareness.

Event Description

Customer complaint alleges "the user was not able to connect the adaptor to flowmeter; when screwing, the connecting part assembly was not properly connected and fell off.Therefore, a new unit was used instead." no patient injury 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.The sample was tested on the dual station lift test and general pull and push test procedures with no functional issues.However, 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.Attempts to duplicate the failure mode were performed and there are two ways to duplicate them: the first one is by overtightening the nut adaptor into the flow meter.The second one is by manipulating the assembly connection.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.Personnel of the assembly line were notified on (b)(6) 2018 for awareness.

Event Description

Customer complaint alleges "the user was not able to connect the adaptor to flowmeter; when screwing, the connecting part assembly was not properly connected and fell off.Therefore, a new unit was used instead." no patient injury 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: 7962215
• MDR Text Key: 123678519
• Report Number: 3004365956-2018-00289
• 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: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/20/2022
• Device Catalogue Number: 031-33J
• Device Lot Number: 74D1701455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Date Manufacturer Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLOWMETER.; FLOWMETER.