MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SZ 3,SILICONE,REUSABLE,LARYNGEAL MASK

Catalog Number DYND280030

Device Problems Break (1069); Crack (1135); Detachment of Device or Device Component (2907)

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

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that during an unidentified procedure the tip of the reusable laryngeal mask cracked and broke off.After multiple good faith attempts the reporting facility was unable or unwilling to provide additional information related to the incident.No impact or adverse effect to a patient or to the unidentified procedure was reported to the manufacturer.A sample was returned to the manufacturer for evaluation.The sample appeared to be in used condition and the plastic connector was found to be cracked and broken off.Cracking of the plastic connector may be due to high temperatures during sterilization.Without additional information related to product handling, use, sterilization, and amount of reuse, a root cause for the reported incident was unable to be determined.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that during an unidentified procedure the tip of the reusable laryngeal mask cracked and broke off.

• Type of Device: SZ 3,SILICONE,REUSABLE,LARYNGEAL MASK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 9241643
• MDR Text Key: 190756760
• Report Number: 1417592-2019-00176
• 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: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/25/2019

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 Catalogue Number: DYND280030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other