MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; SZ 4, PVC, DISPOSABLE, LARYNGEAL MASK

Catalog Number DYND290040

Device Problems Break (1069); Nonstandard Device (1420)

Patient Problem Airway Obstruction (1699)

Event Date 02/21/2022

Event Type  Injury  

Manufacturer Narrative

According to the facility during a procedure after repositioning the patient and airway device the laryngeal mask broke and had to be manually removed using forceps.The issue was discovered by the anesthesiologist during the procedure after turning the patient to a prone position.According to the anesthesiologist, 'they noticed tidal volumes were decreasing and they manually place their fingers into the mouth and the back of the throat to try and reseat the laryngeal mask'.It was then noticed that the 'head of the laryngeal mask had come off and was deep in the airway'.The anesthesiologist was able to remove all pieces of the laryngeal mask and was able to place another laryngeal mask and stabilize the patient to finish the case.The individual is reported to be doing 'ok' with the only impact being a 'sore throat'.A photograph was provided of the device with the noted issue confirmed.The sample was also returned and is awaiting evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the facility during a procedure after repositioning the patient, and the airway device the laryngeal mask broke and had to be manually removed using forceps.

• Type of Device: SZ 4, PVC, DISPOSABLE, LARYNGEAL MASK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13862901
• MDR Text Key: 287703440
• Report Number: 1417592-2022-00041
• 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
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYND290040
• Device Lot Number: 63521050002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: R-22-MED7
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 98 KG