MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN S/L CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	0600524
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes three malfunction events.A review of the events indicated that model 600524 hickman s/l catheters experienced a fluid leak.These reports were received from various sources.Of the three events, all involved patients with no reported injury.One of the patients is a (b)(6)-month-old boy weighing (b)(6) kgs.He was involved in two of the complaints.The other patient was a (b)(6)-month-old boy also weighing (b)(6) kgs.

• Brand Name: HICKMAN S/L CATHETERS
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8529794
• Report Number: 3006260740-2019-01019
• Device Sequence Number: 19314881
• Product Code: LJS
• UDI-Device Identifier: 00801741051814
• UDI-Public: (01)00801741051814
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 0600524
• Device Catalogue Number: 0600524
• Device Lot Number: HUBV0714
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/18/2019
• Patient Sequence Number: 1