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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; CLAMP CANNULA
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; CLAMP CANNULA Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Customer states "it worries us that the possibility of the cannula detaching like what happened a few years ago at hospital (b)(6) is still in the memory of professionals.No adverse patient effects were reported.
 
Event Description
It was further reported that the body of the cannula became detached from the collar.The tube remained inside the patient, but the mother did not realize it, and they tried to install a new cannula by pushing inside the piece of the first cannula.The pediatric patient subsequently underwent a surgical operation to address the incident.No further adverse health effects were reported in relation to this event.
 
Manufacturer Narrative
Other, other text: b5: updated with additional information.
 
Event Description
No product returned.Summary from sme on device engineering.
 
Manufacturer Narrative
Other, other text: no product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.No other analysis was performed.Mitigation: in hra per pwi-10011070 is 100 percent.Visually check that inflation line and pilot balloon is not damaged or contaminated per qp3027 quality takes a sample using an aql 0.15 and level inspections g-i in order to verify the visual inspection and audit leak test.Samples size to be determined based on the expected lot using ansi/asqc z1.4 production performs a 100 percent in process visual inspection, in order to verify that the suction tube is completely bonded to the flange.Production performs a 100 percent.In process weight test to the bonding between the suction line and the flange, in order to ensure that no detachment occurs between the flange and the suction line.Quality control every 2 hours takes 13 processed units, in order to verify that the suction tube is completely bonded to the flange.Root cause: no root cause could determinate since the complaint could not be confirmed since no samples or pictures were received or attached for evaluation.
 
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Type of Device
CLAMP CANNULA
MDR Report Key11580219
MDR Text Key243843326
Report Number3012307300-2021-02562
Device Sequence Number1
Product Code FKC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup,Followup
Report Date 05/26/2021
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 No Information
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/25/2021
Initial Date FDA Received03/28/2021
Supplement Dates Manufacturer Received03/28/2021
04/27/2021
Supplement Dates FDA Received04/27/2021
05/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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