MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FLEXIBLE SIZE 2.5; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Model Number IPN922878

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "a small rupture of a cuff had been discovered in the inspection of a device before inserting in patient.The device was used as per ifu.".

Event Description

It was reported that "a small rupture of a cuff had been discovered in the inspection of a device before inserting in patient.The device was used as per ifu".

Manufacturer Narrative

(b)(4).Additional information received from the customer on 09 jan 2023 states "the cuff ruptured after the functional testing, but it was removed from the packing.No signs of the rupture on the packing.All the devices from this order (3 pcs) have been stored within recommendations.Other 2 pcs have no problems".Upon receipt, the complaint sample look standard and normal from its outer profile.Refer figure 1, photo shared by customer.The original product pouch was not returned.Visual inspection was performed and a cut on the cuff was found.Reviewed on actual sample, identified a stab mark consistent with a thin, sharp blade, that has punctured the cuff.This damage is so overt it would have failed the manufacturing process, wherein there is a requirement to inflate the products and leave them inflated until final inspection and packing.This damage cannot have happened on site.The dhr was reviewed and no abnormality was found.The cause could be potentially related to device handling during the functional test.Other remarks: n/a.Corrected data: n/a.

• Brand Name: LMA FLEXIBLE SIZE 2.5
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; singapore NC 04990 9; SN 049909
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16015915
• MDR Text Key: 306179077
• Report Number: 3013162291-2022-00006
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: LG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN922878
• Device Catalogue Number: 110025
• Device Lot Number: TGAAVS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1