MAUDE Adverse Event Report: TELEFLEX MEDICAL; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 031-28J

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2017

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.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.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 investigation will be updated with the evaluation results.

Event Description

Customer complaint alleges "it was reported that screw thread of adaptor was unable to be attached to flow meter properly prior to use on a patient.Therefore, it was replaced by a new kit." there was no report of patient injury.

Manufacturer Narrative

Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the internal threads of the adaptor were damaged.The damage on the internal thread of the adaptor is not acceptable according to current specifications.Even with that condition, the sample was able to be tested on the dual station lift test and general pull and push test procedures.However, it was not possible to perform the oxygen entrainment testing because the adaptor cannot be connected properly on the oxygen supply due the damage on the internal thread.Based on the investigation performed, the reported complaint was confirmed.The root cause for the issue was found to be the positioning of the thread lead and the softness of the new resin used for the snap adaptor.A capa was opened to address this issue.All production from may 2016 forward is with the updated snap adaptor component.

Event Description

Customer complaint alleges "it was reported that screw thread of adaptor was unable to be attached to flow meter properly prior to use on a patient.Therefore, it was replaced by a new kit." there was no report of patient injury.

• 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: 7137760
• MDR Text Key: 95523334
• Report Number: 3004365956-2017-00465
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/19/2021
• Device Catalogue Number: 031-28J
• Device Lot Number: 74H1602415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2016
• 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