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

Catalog Number 105200-000030

Device Problem Deflation Problem (1149)

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

Event Date 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint received via med watch 0502950000-2017-8007.The device involved in this complaint has not been received by the manufacturer at the time of this report.The investigation into this complaint is still in progress.

Event Description

Customer complaint alleges "crna was preparing for case and lma #3 would no deflate.Crna obtained another lma #3 with same results.Could not deflate lma." (second event captured in companion report #3011137372-2017-00348).There was no report of patient impact or consequence.

Manufacturer Narrative

(b)(4).The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The sample was returned for evaluation.A visual exam was performed and there were no defects observed.Functional testing was also performed on the returned sample and syringe, and it was found that the cuff would inflate and deflate.It was noticed that more force was needed to insert the syringe into the cpv.The size of the outer cylinder was tested with a gauge and it was found that it was within specification; however, it was at the lower range of the required tolerance.The manufacturer reports that a new mold was introduced to production in october 2016.In (b)(6) 2016, it was identified through 100% functional testing 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 teleflex removed the new mold 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 "crna was preparing for case and lma #3 would no deflate.Crna obtained another lma #3 with same results.Could not deflate lma." (second event captured in companion report #3011137372-2017-00348) there was no report of patient impact or consequence.

• Brand Name: LMA UNIQUE SILICONE CUFF PILOT, SIZE 3
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7041921
• MDR Text Key: 93114686
• Report Number: 3011137372-2017-00347
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 11/01/2017

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: Health Professional
• 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: 12/26/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 01/23/2018
• Supplement Dates FDA Received: 01/23/2018
• 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