MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROTECTOR CUFF PILOT SIZE 4

Catalog Number 192040

Device Problem Deflation Problem (1149)

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

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 "before insertion, the user was not able to expel remaining air in the cuff with a syringe." alleged malfunction reported as detected prior to patient use.No report of patient harm.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no physical damage or abnormalities were found on the device.The type of syringe returned was a tapper luer slip.During inflation and deflation testing, difficulty was encountered when inserting the syringe into the cuff pressure valve.Pin gauge test results showed that the inner diameter of the cuff pilot was out of specification.Ten pieces of random samples were chosen from a production lot at the manufacturing facility and subject to a pin gauge test.All samples passed.Functional testing on the complaint sample was performed with two different types of syringes: the syringe returned with the complaint sample, and an in house syringe (tapper luer lock).Both were able to deflate and inflate but it was difficult to insert into the cuff pilot valve.A device history record (dhr) was performed and there were no issues found that could relate to the reported complaint.The inner diameter of the cuff pilot was found to be out of specification.No leaks were detected.The complaint sample was functional; however, the user will experience difficulty inserting the syringe into the cuff pilot as the inner diameter was out of specification.A scar was issued to the supplier.

Event Description

Customer complaint alleges "before insertion, the user was not able to expel remaining air in the cuff with a syringe." alleged malfunction reported as detected prior to patient use.No report of patient harm.

• Brand Name: LMA PROTECTOR CUFF PILOT SIZE 4
• Type of Device: LMA PROTECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; singapore 04990 9; SN 049909
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6826553
• MDR Text Key: 83860437
• Report Number: 9681900-2017-00035
• Device Sequence Number: 1
• Product Code: CAE
• 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: 08/18/2017

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: 12/28/2019
• Device Catalogue Number: 192040
• Device Lot Number: LMCBB4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2017
• Initial Date FDA Received: 08/29/2017
• Supplement Dates Manufacturer Received: 10/16/2017
• Supplement Dates FDA Received: 10/16/2017
• 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