MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DECATHLON DF LONG-TERM HEMODIALYSIS CATHETER STANDARD KIT (16F) (DUAL-LUMEN); BLOOD ACCESS DEVICE AND ACCESSORIES

Model Number	DF19SH24K
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the patient was sent to the facility for replacement of his decathlon dialysis catheter, due to a broken white plastic clamp.There was no reported patient injury.

• Brand Name: DECATHLON DF LONG-TERM HEMODIALYSIS CATHETER STANDARD KIT (16F) (DUAL-LUMEN)
• Common Device Name: BLOOD ACCESS DEVICE AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7426173
• Report Number: 3006260740-2018-00677
• Device Sequence Number: 10789797
• Product Code: MSD
• UDI-Device Identifier: 00801741013942
• UDI-Public: (01)00801741013942
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K033294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2018

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: Health Professional
• Device Model Number: DF19SH24K
• Device Catalogue Number: DF19SH24K
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74
• Patient Weight: 67