MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN 9.0FR D/L PED; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	0600580
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes two malfunction events.A review of the events indicated that model 0600580 hickman 9.0 fr d/l ped experienced a missing component.These reports were received from various sources.Neither event involved patients.The 0600580 hickman 9.0 fr d/l ped were returned to the manufacturer for evaluation and are pending investigation.
Additional Manufacturer Narrative
H10: of the 3 devices, 3 lot numbers were provided, and lot history reviews were performed.Of the 3 reported malfunctions, 3 devices were returned for evaluation.Dimensional evaluations were performed.The investigation is unconfirmed for incorrect component, as the device was within the limits set by the drawing corresponding to the part in question.No root cause could be identified.
Event or Problem Description
This report summarizes three malfunction events.A review of the events indicated that model 0600580 hickman 9.0fr d/l ped experienced a missing component.These reports were received from various sources.Neither event involved patients.

• Brand Name: HICKMAN 9.0FR D/L PED
• 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: 8533130
• Report Number: 2020394-2019-00500
• Device Sequence Number: 11165803
• Product Code: LJS
• UDI-Device Identifier: 00801741051883
• UDI-Public: (01)00801741051883
• 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,Followup
• Report Date (Section B): 07/23/2019

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: 0600580
• Device Catalogue Number: 0600580
• Device Lot Number: HUCV1842, HUCX0010
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1