MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN CV CATHETER, DUAL-LUMEN, 9F; CHRONIC CATHETER

Model Number	0600330
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a lot history review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation is inconclusive for the reported catheter break.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0600330 chronic catheter allegedly experienced break.This information was received from (b)(6).The one reported malfunction involved one patient with no consequences.The age, sex and weight of the patient was not provided.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a lot history review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation is inconclusive for the reported fracture.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H11:section a through f - the information provided by bd 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 bd.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0600330 chronic catheter allegedly experienced fracture.This information was received from one source.The one reported malfunction involved one patient with no consequences.Age, weight and gender were not provided.

• Brand Name: HICKMAN CV CATHETER, DUAL-LUMEN, 9F
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10733080
• Report Number: 3006260740-2020-03461
• Device Sequence Number: 1114796
• Product Code: LJS
• UDI-Device Identifier: 00801741051753
• UDI-Public: (01)00801741051753
• 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): 01/07/2021

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: 0600330
• Device Catalogue Number: 0600330
• Device Lot Number: HUBX2666
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 01/07/2021
• Patient Sequence Number: 1