MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT, 14.5 FR, ST, 23CM, MI, W/STIFF WIRE; DIALYSIS 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	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 05/2019).
Event or Problem Description
It was reported that approximately six months post dialysis catheter use, there was alleged emulsification of the catheter.There was no reported patient injury.
Event or Problem Description
It was reported that approximately six months post dialysis catheter use, there was alleged emulsification of the catheter.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this 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.Investigation summary: one electronic photo was reviewed.The photo shows part of a hemosplit dialysis catheter implanted in a patient.Most of the catheter shaft is not visible and the hubs are not in the photo.The device appears to be in use, as blood can be seen in the extension legs.The device appears to be sutured to the patient¿s skin at the suture holes in the suture wings.The clamps appear to not be engaged.One of the extension legs appears to have a slight crease mark near the clamp.There appears to a milky white substance in both extension legs near the bifurcation.The extension legs appear to have slight bulging just proximal to the bifurcation and one of the extension legs appears to be slightly bent just proximal to the bifurcation in the bulging region.This apparent deformation is in the region of the milky white substance.Based on the photo review, accumulation of residue in the extension legs and slight deformation can be confirmed.Although the sample was not returned for evaluation, one electronic photo was provided for review.The investigation is conclusive for a white coloration in the extension legs and slight material deformation at the extension legs, as a milky white color and slight bulging and bending just proximal to the bifurcation was observed.The definitive root cause could not be determined based upon available information.Conclusion: results:.

• Brand Name: HEMOSPLIT, 14.5 FR, ST, 23CM, MI, W/STIFF WIRE
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9211599
• Report Number: 3006260740-2019-03235
• Device Sequence Number: 409582
• Product Code: MSD
• UDI-Device Identifier: 00801741013287
• UDI-Public: (01)00801741013287
• Combination Product (Y/N): N
• PMA/510(K) Number: K030020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5743730
• Device Catalogue Number: 5743730
• Device Lot Number: RECN1264
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1