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

Model Number	0600620
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Of the 2 devices, 2 lot numbers were provided, and lot history reviews were performed.Of the 2 reported malfunctions, devices were not returned for evaluation.For the reported two malfunctions, the investigation is inconclusive for fracture.Based upon the available information, the definitive root cause is unknown.The devices were labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicates that model 0600620 catheter, intravascular, therapeutic, long-term greater than 30 days allegedly experienced fracture.The information was received from various sources.Of the two malfunctions, both involved patients with no patient consequences.The age, weight, and gender were not provided for both patients.

• Brand Name: HICKMAN D/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: 10286144
• Report Number: 3006260740-2020-02485
• Device Sequence Number: 2679700
• Product Code: LJS
• UDI-Device Identifier: 00801741051913
• UDI-Public: (01)00801741051913
• 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): 07/16/2020

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: 0600620
• Device Catalogue Number: 0600620
• Device Lot Number: HUDW2501, HUDW1925
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/16/2020
• Patient Sequence Number: 1