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U.S. Department of Health and Human Services

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

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MEDLINE INDUSTRIES INC.; SZ 3,SILICONE,REUSABLE,LARYNGEAL MASK Back to Search Results
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.
 
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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 Key9241643
MDR Text Key190756760
Report Number1417592-2019-00176
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 NumberDYND280030
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2019
Initial Date Manufacturer Received 10/01/2019
Initial Date FDA Received10/25/2019
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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