MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNKNOWN CHRONIC CATHETER

Catalog Number UNK CHRONIC CATHETER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 05/30/2018

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Journal article citation: martynov, i., raedecke, j., klima-frysch, j., kluwe, w., & schoenberger, j.(2018).Outcome of landmark-guided percutaneously inserted tunneled central venous catheters in infants and children under 3 years with cancer.Pediatric blood & cancer, 65(10).Doi: 10.1002/pbc.27295.

Event Description

It was reported in an article from the journal of american society of pediatric hematology/oncology titled " outcome of landmark-guided percutaneously inserted tunneled central venous catheters in infants and children under 3 years with cancer " that after tunneled central venous catheters (tcvc) insertion in pediatric patients, catheter-related bloodstream infection and/or local skin inflammation (exit-site infections and/or tunnel infections) originating from the catheter, leading to device removal was identified in 16 patients.During catheter insertion, conversion to cut-down venotomy was necessary in one patient.The status of the patients and intervention details were not provided.

• Brand Name: UNKNOWN CHRONIC CATHETER
• Type of Device: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, road #3, km 79.7; humacao 00791
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9546997
• MDR Text Key: 174527960
• Report Number: 3006260740-2019-04044
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CHRONIC CATHETER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention