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

Model Number	DF35SH40K
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
Event or Problem Description
It was reported that during an over-the-wire catheter exchange, as the catheter was inserted into the tunnel under the skin, the physician noticed a split in the catheter from the cuff to the suture wings.A new device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the dhr review is not available because the corporate lot number is unknown.Investigation summary: based on the sample evaluation: one decathlon df 35 cm d/l catheter with surecuff was returned for evaluation.Visual and functional evaluations were performed.The investigation is unconfirmed for fluid leak (ext leak/break/split w/o embo), as no leaks or splits were observed during the leak test on the device.Since the problem could not be reproduced there is no root cause summary.Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Pma/510k device evaluated by mfr (result 1, conclusion1).
Event or Problem Description
It was reported that during an over-the-wire catheter exchange, as the catheter was inserted into the tunnel under the skin, the physician noticed a split in the catheter from the cuff to the suture wings.A new device was used to complete the procedure.There was no reported patient injury.

• Brand Name: DECATHLON DF LONG-TERM HEMODIALYSIS CATHETER STANDARD KIT (16F) (DUAL-LUMEN)
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7603500
• Report Number: 3006260740-2018-01394
• Device Sequence Number: 10831845
• Product Code: MSD
• UDI-Device Identifier: 00801741014024
• UDI-Public: (01)00801741014024
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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: Health Professional
• Device Model Number: DF35SH40K
• Device Catalogue Number: DF35SH40K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 125