MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. SHERLOCK 3CG TCS; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Device Problem Malposition of Device (2616)

Patient Problem Swelling (2091)

Event Date 05/23/2018

Event Type  Injury  

Event Description

The patient has difficult peripheral access with contractures in both arms.The decision was made to place a peripherally inserted central catheter (picc) line at the bedside mid-(b)(6) 2018.The following day, the medical team identified right upper arm swelling extending into the chest.An ultrasound was performed and identified that the picc line was inserted into the right brachial artery extending into the right axillary and subclavian arteries.The line had been used for antibiotic infusions for one day.The picc line was removed.Vascular surgery was consulted.Additional ultrasound studies were ordered and completed.The patient was prescribed for full strength aspirin daily.A duplex scan was ordered and scheduled to be completed in six weeks.The patient discharged to home seven days after picc line insertion.Manufacturer response for sherlock 3cg tcs, bard double lumen 4fr.Small vessel power picc with sherlock (per site reporter).Thank you for taking some time to speak with me and the bd clinical nurse specialist, yesterday in regards to the picc malposition occurrence when using the site~rite 8 ultrasound system and sherlock 3cg sensor.I have opened a product complaint file for an internal investigation.If you have any additional information to add to the case file, let me know and i can have the information submitted for you.

• Brand Name: SHERLOCK 3CG TCS
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 7613864
• MDR Text Key: 111498506
• Report Number: 7613864
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2018,06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Other Device ID Number: BARD DOUBLE LUMEN 4FR. SMALL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DOUBLE LUMEN 4FR PICC LINE (SMALL VESSEL POWER
• Patient Outcome(s): Other
• Patient Age: 35 YR