MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BROVIAC 4.2 FR SINGLE-LUMEN CV CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	0600524
Health Effect - Clinical Codes	Cyst(s) (1800); Edema (1820); Inflammation (1932); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of huas1705 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per medwatch report, the facility reported a 4.2fr broviac cvc, when removed by gentle traction removal, allowed for the silicone cuff to be retained in a pediatric patient.The cuff migrated out of the patient's subcutaneous anterior chest tissue with abscess formation.The cuff had to be removed surgically.

• Brand Name: BROVIAC 4.2 FR SINGLE-LUMEN CV CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6886750
• Report Number: 3006260740-2017-01670
• Device Sequence Number: 16308499
• Product Code: LJS
• UDI-Device Identifier: 00801741051814
• UDI-Public: (01)00801741051814
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K830256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/22/2017
• Report Date (Section F): 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0600524
• Device Catalogue Number: 0600524
• Device Lot Number: HUAS1705
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 MO
• Date Report Sent to FDA: 08/24/2017