MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE CUFF) CPV SIZE 3; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 105200-000030

Device Problem Sticking (1597)

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

Event Date 05/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges "prior to use on a patient during a fibro bronchoscopy, it was noticed that the spring of cuff pilot got stuck." there was no patient impact or consequence reported.

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The device was manufactured according to release specification.The sample was returned and sent to the manufacturer (tianjin medis) for evaluation.Tianjin reports that a new mold was introduced to production in october 2016.In (b)(6) 2016, it was identified through 100% functional test that it may not be as easy to insert the syringe into the female conical fitting (luer) of the cuff pilot produced on this new mold.The device passed the required release criteria.At this time the new mold was removed and reverted to the original mold.Upon investigation, it was found that the drawing stipulating the inner diameter of the female conical fitting (luer) for the cuff pilot was not sufficiently clear with respect to the tolerance range.This allowed for devices to be manufactured closer to the lower range of the required tolerance, however the device was manufactured within tolerance therefore the complaint could not be confirmed.At this lower range, it may not be as easy for the user to insert the syringe into the female conical fitting (luer).

Event Description

Customer complaint alleges "prior to use on a patient during a fibro bronchoscopy, it was noticed that the spring of cuff pilot got stuck." there was no patient impact or consequence reported.

• Brand Name: LMA UNIQUE (SILICONE CUFF) CPV SIZE 3
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 7610620
• MDR Text Key: 111393236
• Report Number: 3011137372-2018-00162
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

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: 11/01/2019
• Device Catalogue Number: 105200-000030
• Device Lot Number: LQAFNB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 07/26/2018
• Supplement Dates FDA Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1