MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER

Model Number	5743730
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A photo has been provided for review.The lot number for the device was provided.The device history records are currently under review.The device has not been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that approximately ten months post catheter placement, the extension leg allegedly turned white and deformed.It was further reported that the deformation got worse over time and allegedly affected blood flow volume.There was no reported patient injury.
Event or Problem Description
It was reported that approximately ten months post catheter placement, the extension leg allegedly turned white and became deformed.It was further reported that the deformation continued and affected blood flow volume.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was performed.The lot met all release criteria.Investigation summary: two electronic photos of a hemosplit catheter were returned for evaluation.A photo review was performed.The investigation is confirmed for material deformation, specifically for kinking in the extension leg, as kinking in the extension leg was observed in both photos.Parts of the extension legs also had a milky white color.The definitive root cause could not be determined based upon available information.The extension legs are made of tecothane and tecothane is known to ¿take a set¿ in areas where it has been clamped.Repeated bending and/or clamping at the same location on the extension leg may have contributed to the reported event.Vt-capa-18-036 has been opened to address the issue of dialysis catheter extension leg kinking.Physiological, chemical, material and mechanical factors may have also contributed to the reported event.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.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.

• Brand Name: HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8533484
• Report Number: 3006260740-2019-01113
• Device Sequence Number: 11082168
• Product Code: MSD
• UDI-Device Identifier: 00801741013287
• UDI-Public: (01)00801741013287
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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: 5743730
• Device Catalogue Number: 5743730
• Device Lot Number: REAV1687
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 67