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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LLC CATHETER PASSER; CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TER
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COVIDIEN LLC CATHETER PASSER; CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TER Back to Search Results
Model Number 48409
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2021
Event Type  malfunction  
Event Description
Medtronic received information regarding a catheter.It was reported that something happened to the catheter.
 
Manufacturer Narrative
Initial report not known from the site.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
CATHETER PASSER
Type of Device
CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TER
Manufacturer (Section D)
COVIDIEN LLC
15 hampshire street
mansfield 02048
Manufacturer (Section G)
COVIDIEN LLC
15 hampshire street
mansfield 02048
Manufacturer Contact
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key13079086
MDR Text Key282725679
Report Number9612501-2021-02144
Device Sequence Number1
Product Code MAJ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K911382
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number48409
Device Catalogue Number48409
Device Lot Number0221052536
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/03/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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