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 at the time of this report.However, visual and functional inspection was performed to 42 production samples of code ip-5035 batch 74l1702785 taken randomly from assembly line.Catalog number ip-5035 uses the same subassembly ph12136 than catalog number 031-28 related to this customer complaint.No issues or discrepancies were found than can lead to the condition reported by the customer.A device history record review shows that the device was assembled and inspected according to our specifications.Customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation to confirm the alleged defect and determine the root cause.If the device sample becomes available this report will be updated with the evaluation results.

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".

Manufacturer Narrative

(b)(4).The actual sample was not returned; however, the customer returned five unopened representative samples for evaluation.A visual exam was performed and no issues were observed.Functional testing was also performed and no issues were encountered.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned representative samples.

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: 7120636
• MDR Text Key: 95064695
• Report Number: 3004365956-2017-00423
• 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: 11/29/2017

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 Catalogue Number: 031-28
• Device Lot Number: 74A1502218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 01/19/2018
• Supplement Dates FDA Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2015
• 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