MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMO CATH & PIK; LONG-TERM HEMODIALYSIS CATHETER

Model Number	0600660
Medical Device Problem Codes	Fracture (1260); Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device for this event has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 600660 long term hemodialysis catheter allegedly had defective components.This information was received from one source.The malfunction involved a patient without consequence.The patient age, weight, and sex were not provided.
Additional Manufacturer Narrative
H10: for this event, the lot number was provided and a lot history review was performed.Of the 1 reported malfunction, 1 device was returned for evaluation.A complete catheter fracture was confirmed for this device.A root cause has not been determined.The device was labeled for single use.H10:g4.H11: h6 ( eval, conclusion).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 600660 long term hemodialysis catheter allegedly had defective components.This information was received from one source.The malfunction involved a patient without consequence.The patient age, weight, and sex were not provided.

• Brand Name: HEMO CATH & PIK
• Common Device Name: LONG-TERM HEMODIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8817716
• Report Number: 3006260740-2019-02108
• Device Sequence Number: 19468055
• Product Code: LJS
• UDI-Device Identifier: 00801741037504
• UDI-Public: (01)00801741037504
• 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): 10/09/2019

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: 0600660
• Device Catalogue Number: 0600660
• Device Lot Number: REDN0077
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 10/11/2019
• Patient Sequence Number: 1