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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; BREATHING-CIRCUIT
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; BREATHING-CIRCUIT Back to Search Results
Model Number C49101320J
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2020
Event Type  malfunction  
Event Description
It was reported that during the use of the smiths medical product, the corrugated tube suddenly got torn off.No patient injury.
 
Manufacturer Narrative
Device evaluation- one sample was returned for evaluation.Visual inspection showed the tube had a tear which would have allowed for leakage.The manufacturing facility performed a review of the manufacturing process.The review showed that assembly process was being performed as per procedures.During production this device type is sampled for inspection to ensure corrugated areas of the tube are not crushed or dented.The investigation determined the most likely cause of the issue was damage occurring during use.
 
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Type of Device
BREATHING-CIRCUIT
MDR Report Key10909942
MDR Text Key218647927
Report Number3012307300-2020-11829
Device Sequence Number1
Product Code CAG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/11/2021
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 Model NumberC49101320J
Device Catalogue NumberC49101320J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/26/2020
Initial Date FDA Received11/26/2020
Supplement Dates Manufacturer Received12/13/2020
Supplement Dates FDA Received01/11/2021
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 N
Patient Sequence Number1
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