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

Catalog Number 031-33J

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2017

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.However samples of code 031-33j batch 74f1700608 that were taken randomly from assembly line.During the testing 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.In order to perform a proper investigation and determine the root cause it is necessary to have the device involved in the complaint.If the sample becomes available this investigation will be updated with the evaluation results.

Event Description

Customer complaint alleges "during preparation prior to use, sterilized water could not be sprayed out from the nebulizer adaptor." alleged defect reported as in preparation for patient use.No report of patient injury or consequence.A new unit was obtained for use.

Manufacturer Narrative

Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was contamination on the internal thread of the adaptor.It was also noticed that the aspirator and upper body of the nebulizer were assembled incorrectly.Functional testing was performed and during the testing it was observed that water sprayed out in the wrong direction inside the adaptor causing the issue reported by the customer.Based on the investigation performed, the reported complaint was confirmed.A non-conformance has been opened to address this issue.In addition, personnel from the assembly line at the manufacturing facility were notified for awareness.

Event Description

Customer complaint alleges "during preparation prior to use, sterilized water could not be sprayed out from the nebulizer adaptor." alleged defect reported as in preparation for patient use.No report of patient injury or consequence.A new unit was obtained for use.

• Brand Name: 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: 6667777
• MDR Text Key: 78482985
• Report Number: 3004365956-2017-00264
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2017

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: 10/21/2021
• Device Catalogue Number: 031-33J
• Device Lot Number: 74K1602201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 06/26/2017
• Supplement Dates Manufacturer Received: 08/25/2017
• Supplement Dates FDA Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2016
• 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