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

Catalog Number 031-33J

Device Problem Connection Problem (2900)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2017

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the defect was not received by the manufacturer at the time of this report.A device history record review shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based on the information received.It is necessary to have the physical device sample in order to perform a proper investigation to confirm the alleged defect reported, and establish corrective actions.However, the personnel of the assembly line were notified for awareness if the product sample becomes available this report will be updated accordingly.

Event Description

Customer complaint alleges "the adaptor couldn't attach to the oxygen flow meter straight.(the adaptor was connected aslant to the flowmeter.)" issue reported as detected prior to patient use.A new device was used instead.No report of patient involvement.No report of delay in treatment.

Manufacturer Narrative

(b)(4).The sample was received for evaluation.A visual exam was performed and it was observed that the nut adaptor did not spin freely.No other issues were found.Functional testing was also performed and no issues were found.It was noticed, however, that during the oxygen entrainment test the assembly of the nut adaptor and the upper body was unstable.Even with that condition, the testing was able to be performed, and the sample passed the test.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.

Event Description

Customer complaint alleges "the adaptor couldn't attach to the oxygen flow meter straight.(the adaptor was connected aslant to the flowmeter.)" issue reported as detected prior to patient use.A new device was used instead.No report of patient involvement.No report of delay in treatment.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6794282
• MDR Text Key: 82955532
• Report Number: 3004365956-2017-00326
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/07/2017

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: 11/03/2021
• Device Catalogue Number: 031-33J
• Device Lot Number: 74L1600507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2017
• Initial Date FDA Received: 08/15/2017
• Supplement Dates Manufacturer Received: 10/02/2017
• Supplement Dates FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1