MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (19CM); CATHETER, HEMODIALYSIS, IMPLANTED

Model Number 5833690

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2018

Event Type  malfunction  

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 is pending return 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 Description

It was reported the catheter extension tube disconnected.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: 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.Investigation summary: one d/l hemostar catheter was returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is confirmed for extension leg separation from bifurcation, as the blue hub extension leg was separated from the bifurcation and break surfaces were observed on the distal end of the extension end and the proximal end of the bifurcation on the main catheter.The break surfaces appeared smooth and had striations mostly aligned towards the center of the lumen.Some damage was observed near the inner edge on the extension leg break surface.The definitive root cause could not be determined based upon available information.It is unknown if procedural issues contributed to the reported event.Excessive and/or repeated stresses and/or torques may have contributed to the reported extension leg separation from the bifurcation.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.H10: d4 (expiration date: 07/2019), d10, g4, h6 (device codes).H11: h3, h6 (method, results, conclusions).H11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported the catheter extension tube disconnected.There was no reported patient injury.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (19CM)
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7719616
• MDR Text Key: 115011928
• Report Number: 3006260740-2018-01825
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013386
• UDI-Public: (01)00801741013386
• Combination Product (y/n): N
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/03/2019

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
• Device Operator: Health Professional
• Device Model Number: 5833690
• Device Catalogue Number: 5833690
• Device Lot Number: REBV1809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/25/2018
• Supplement Dates Manufacturer Received: 03/27/2019
• Supplement Dates FDA Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1