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 has holes in the hub.The catheter remains in the patient.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was required.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: one electronic video was reviewed by bdpi field assurance engineer.The photo shows a dual lumen catheter labeled ¿decathlon 27 cm.¿ the device was inserted into a patient and sutured down.The device was flushed through the blue-hubbed extension leg after clamping and during infusion a gloved hand was brought near the blue hub to show that infusate was spraying from the tubing just distal to the white collar.Based on the photo review, the reported leak is confirmed.The definitive root cause could not be determined based upon available information as the returned sample was a non-original product sample.It is unknown if procedural issues contributed to the reported event.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 has holes in the hub.The catheter remains in the patient.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: 7561490
• Report Number: 3006260740-2018-01183
• Device Sequence Number: 14002028
• 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 Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2018

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: REBV1236
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 09/05/2018
• 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