MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SZ 4, DISP, SOFT, MASK, LARYNGEAL, PVC

Catalog Number DYND300040S

Device Problems Material Too Rigid or Stiff (1544); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 04/23/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that during use of the laryngeal mask airway (lma) for an elective case, the lma's cuff was noted stiff.This reportedly resulted in the lma cuff not seating correctly in the patient's airway and the patient developing laryngospasm.Per report, during insertion, lubricating water-based jelly was used and lma was partially deflated before inserting into patient.As soon as the laryngeal mask was inflated with 5 cc of air, the patient reportedly developed laryngospasm.The laryngeal mask airway was immediately removed, patient was given succinylcholine (drug), and another brand of laryngeal mask airway was inserted.No further tests/treatment was reportedly required for the patient's laryngospasm.Due to the reported laryngospasm and required medical intervention, this medwatch is being filed.No issues with the returned companion sample was identified.A definitive root cause for the reported event could not be identified at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the laryngeal mask airway's (lma) cuff was stiff resulting in the lma not seating correctly in the patient's airway and the patient developing laryngospasm.

• Type of Device: SZ 4, DISP, SOFT, MASK, LARYNGEAL, PVC
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8663935
• MDR Text Key: 146908923
• Report Number: 1417592-2019-00081
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 10888277699526
• UDI-Public: 10888277699526
• 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,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/03/2019

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: DYND300040S
• Device Lot Number: 59219020326
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention