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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CENTRAL VENOUS CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC

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CENTRAL VENOUS CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 04/05/2018
Event Type  Injury  
Event Description
Infection associated with central venous catheter, (b)(6) year old female with crohn's disease and indwelling left port and concern for infection - (as extracted from d/c summary source record) - "you were admitted to the hospital with an infection around the skin of your port site. We have removed the port. You did not have any bacteria grow from your blood or the port itself at this time. We have transitioned you to two oral antibiotics which you will need to continue for an additional 7 days. A picc line was placed so that you can continue to receive your iv infusions at home. You should contact dr. To set up another insertion for a port. It is recommended that you see her sometime next week to make sure the infection is resolving. " admit: (b)(6) 2018 / disch: (b)(6) 2018.
 
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Brand NameCENTRAL VENOUS CATHETER
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
MDR Report Key9391841
MDR Text Key168471013
Report NumberMW5091369
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/27/2019 Patient Sequence Number: 1
Treatment
0.9NACL 2 GRAM/50ML PGBK, INFUSE4 7.5G INTO VENOUS CATHETER EVERY 3RD DAY. ; AMLODIPINE 5MG; CELECOXIB 200MG; CO Q-10 200MG; CYANOCOBALAMIN 1000MCG/ML, INJECTION; CYCLOBENZAPRINE 10MG TAB; DEPHENOXYLATE-ATROPINE 2.5-0.025MG, 1 TAB; FLUCONAZOLE 200MG, 1 TAB; HYDROMORPHONE 2MG; MAGNESIUM SULFATE IN ; PREGABALIN 225MG, 1 CAPSULE BID ; SODIUM CHLORIDE 0.9% BOLUS, INFUSE 1000ML INTO VENOUS CATHETER EVERY 3RD DAY ; STELARA 90MG/ML, INJECT 1ML SQ Q7WEEKS (LAST DOSE (B)(6) 2018, NEXT DOSE GIVEN (B)(6) 2018); VERAPAMIL 180MG, 2 TAB NIGHTLY
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