MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (35CM); CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	5833350
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records 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.Photographs have 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 the catheter disconnected at the arterial end connector.After insertion it was found that the connection between the catheter connector and the catheter was loose, the catheter and connecter were adjusted and the connector completely detached.The device was immediately removed and another catheter was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
No medical records 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.Photographs have been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 05/2019).
Event or Problem Description
It was reported that the catheter disconnected at the arterial end connector.After insertion it was found that the connection between the catheter connector and the catheter was loose, the catheter and connecter were adjusted and the connector completely detached.The device was immediately removed and another catheter was used to complete the procedure.There was damage to the tissue when the catheter was surgically removed.There was no reported patient injury.
Event or Problem Description
It was reported that the catheter disconnected at the arterial end connector.After insertion it was found that the connection between the catheter connector and the catheter was loose, the catheter and connecter were adjusted and the connector completely detached.The device was immediately removed and another catheter was used to complete the procedure.There was damage to the tissue when the catheter was surgically removed.There was no reported patient injury.
Additional Manufacturer Narrative
The device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.One dialysis catheter was returned for evaluation.Visual and microscopic inspection identified a complete circumferential break at the distal end of the arterial hub/strain relief.Therefore, the investigation is confirmed for the alleged hub detachment.The most likely root cause of the reported hub detachment is clamping too close to the strain relief.However, the definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(b)(4).

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (35CM)
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7868365
• Report Number: 3006260740-2018-02417
• Device Sequence Number: 1938894
• Product Code: MSD
• UDI-Device Identifier: 00801741013362
• UDI-Public: (01)00801741013362
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2018

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: 5833350
• Device Catalogue Number: 5833350
• Device Lot Number: RECN1012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Received by Manufacturer: 08/19/2018
• Supplement Date Received by Manufacturer: 10/23/2018; 11/28/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 11/20/2018; 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 45