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

Catalog Number 031-28

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2017

Event Type  malfunction  

Manufacturer Narrative

(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 alleged defect was not provided.Device history record review shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information received.In order to perform a proper investigation to confirm the alleged defect and determine the root cause it is necessary to have the device sample.If the device becomes available, this report will be updated with the evaluation results.Teleflex will continue to monitor for similar complaints.

Event Description

Customer complaint alleges "we tried to screw the product on oxygen outlet on the wall.It would not attach / screw on to the oxygen tip." alleged issue reported as occurring during use.It was reported there was not injury to the patient.A different device was obtained for use.Patient's condition reported as "fine".

Manufacturer Narrative

(b)(4).The customer did not return the actual sample for evaluation; however, they did return an unopened representative sample from the same lot number.A visual exam was performed and no defects were observed.Functional testing was performed - dual station lift test, general pull and push test procedures, and oxygen entrainment testing, and no issues were encountered during the testing.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned representative sample.

Event Description

Customer complaint alleges "we tried to screw the product on oxygen outlet on the wall.It would not attach / screw on to the oxygen tip." alleged issue reported as occurring during use.It was reported there was not injury to the patient.A different device was obtained for use.Patient condition reported as "fine".

• Brand Name: HUDSON NEBULIZER ADAPTOR 028,SHELFPAK
• 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: 7125668
• MDR Text Key: 95519213
• Report Number: 3004365956-2017-00422
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• 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: 74C1503627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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