MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE, SU, SIZE 2.5; LARYNGEAL MASK AIRWAY

Catalog Number 125025

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 11/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the device sample was not returned for evaluation at the time of this report.

Event Description

The event is reported as: the customer alleges a different expiration date printed on product than on the sticker that is applied to the product.There is no reported patient involvement.

Manufacturer Narrative

(b)(4).Device history record (dhr) review was performed and there were no issues found that could have contributed to the reported failure.The used device was not received in the original teleflex lma packaging.The airway tube was observed to be clear.The complaint device was observed to be unpacked upon receipt.There was no physical damage to the device.Traceability of this lot has been performed and it was noted that an extension of the expiration date (validated) was allowed for the reported lot.Therefore the sterility of the product is not compromised.The reported defect is unconfirmed.The original expiration date 07/28/2016 was extended to 11/28/2016 therefore the device was still within the extension period.

Event Description

The event is reported as: the customer alleges a different expiration date printed on product than on the sticker that is applied to the product.There is no reported patient involvement.

• Brand Name: LMA UNIQUE, SU, SIZE 2.5
• Type of Device: LARYNGEAL MASK AIRWAY
• 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: warrenda peterson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193613959
• MDR Report Key: 6145268
• MDR Text Key: 61455072
• Report Number: 9681900-2016-00055
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2016

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 Catalogue Number: 125025
• Device Lot Number: HEA9QV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/17/2017
• 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