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

Model Number	DF27IT32K
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2018
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 provided, a review of the device history records is currently being 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 the catheter had poor flow as a result of holes in the hub.The catheter was removed and replaced with a new device.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: dhr was reviewed and no deviations/issues were identified associated with this problem in regards to product materials or during packaging, manufacturing or qc inspection processes.All necessary inspections were performed throughout all the manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot, in regards the problem described.Investigation summary: the sample returned for evaluation was one 27 cm decathlon catheter.Leak testing, examination of the damage, and replication of the damage using non-complainant samples was performed.Holes in the arterial extension leg were confirmed and were found to be consistent with damage caused by clamping with a guidewire installed.Therefore the investigation is confirmed for leak and also confirmed for stylet damage.Per the reported event details, the user detected holes in the extension legs.Sample evaluation revealed that the extension leg clamp was deployed with a guidewire present within the lumen, resulting in the holes reported.The instructions for use (ifu) states, ¿4.Flush each lumen with heparin solution prior to insertion and clamp the extension legs.If using stylet, do not clamp the arterial (red) lumen until the arterial insertion stylet and guidewire are removed.Clamping will kink the stylet and prevent guidewire passage.¿ and "if not using a stylet, the proximal end of the guidewire must be inserted into the small venous end hole of the distal-most tip, and threaded into the end hole of the arterial tip, passing through the arterial lumen until it extends out the arterial luer-lock connector (red).If using stylet, thread the proximal end of the guidewire through the distal tip of the stylet until the guidewire extends out the stylet luer-lock connector." therefore, the root cause for the reported and identified issues was determined to be user-related.Labeling review: a review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, cautions, possible complications and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported the catheter had poor flow as a result of holes in the hub.The catheter was removed and replaced with a new device.There was no reported patient injury.

• Brand Name: DECATHLON DF LONG-TERM HEMODIALYSIS CATHETER INTERMEDIATE 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: 7561491
• Report Number: 3006260740-2018-01182
• Device Sequence Number: 2281694
• Product Code: MSD
• UDI-Device Identifier: 00801741013973
• UDI-Public: (01)00801741013973
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K033294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2018

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: DF27IT32K
• Device Catalogue Number: DF27IT32K
• Device Lot Number: REBX0926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 95