MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA MAD NASAL WITHOUT SYRINGE; NEBULIZER, MEDICINAL,NON-VENTILATORY

Catalog Number MAD300

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No sample device was returned at the time of this report.There was no photo for review.Therefore no testing or physical evaluation was able to be performed.A device history record review for the device lot number reported showed no issues related to this complaint.All testing methods performed by qa on this batch were found to be acceptable.The customer complaint cannot be confirmed based only on the information received.If the device becomes available at a later date this report will be updated accordingly.

Event Description

Customer complaint alleges the "anesthetic could not be sprayed out from the atomizer".Alleged malfunction reported to have occurred during use.A new device was used instead.It was reported there was no medical intervention necessary.Patient condition was reported as "fine".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed on the sample was it was observed that there was an occlusion on the tip.Functional testing was also performed and the occlusion was confirmed.A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.Based on the investigation performed, the reported complaint was confirmed.The root cause is attributed to excessive solvent on the tip, causing a blockage of the atomization hole.This operation is done manually, the root cause is related to operator error.This is considered to be an isolated event as the product was manufactured 29-oct-2015 and no other complaints for this issue have been received from june 2014 to present.A non-conformance was opened to address this issue.

Event Description

Customer complaint alleges the "anesthetic could not be sprayed out from the atomizer".Alleged malfunction reported to have occurred during use.A new device was used instead.It was reported there was no medical intervention necessary.Patient condition was reported as "fine".

• Brand Name: LMA MAD NASAL WITHOUT SYRINGE
• Type of Device: NEBULIZER, MEDICINAL,NON-VENTILATORY
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): WOLFE TORY MEDICAL INC.; 79w 4500 s suite 18; salt lake city UT 84107
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6568572
• MDR Text Key: 75236844
• Report Number: 1722554-2017-00002
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/29/2018
• Device Catalogue Number: MAD300
• Device Lot Number: 151037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2017
• 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