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

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.

• Brand Name: CENTRAL VENOUS CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• MDR Report Key: 9391841
• MDR Text Key: 168471013
• Report Number: MW5091369
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• 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 Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 91