MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT, 14.5 FR, ST, 19CM, STAND KIT; DIALYSIS CATHETER

Model Number 5703690

Device Problems Material Opacification (1426); Stretched (1601); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2019

Event Type  malfunction  

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: 01/2021).

Event Description

It was reported that approximately three months seventeen days post dialysis catheter placement, a bulge was allegedly found on the catheter.Reportedly, the dialysis catheter was replaced.There was no reported patient injury.

Event Description

It was reported that approximately three months seventeen days post dialysis catheter placement, a bulge was allegedly found on the catheter.Reportedly, the dialysis catheter was replaced.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: two electronic photos were reviewed.The photo shows a hemodialysis catheter implanted in the patient.A portion of the extension legs and bifurcation are visible.There appears to be a milky white color on both extension legs near the bifurcation, and there appears to be bulging in one of the extension legs in the milky white colored region near the bifurcation.The photo shows the catheter at an angled view.The bifurcation, suture wings, clamps and a portion of the extension legs are visible.The milky white coloration on one of the extension legs is visible, and there appears to be a bend/kink in one of the extension legs in the milky white colored region just proximal to the bifurcation.Based on the photo review, extension leg opacification, bulging and bending/kinking can be confirmed.Although the sample was not returned for evaluation, two electronic photos were provided for review.The investigation is confirmed for opacification and deformation of extension legs, as the photo review identified a milky white color, bulging and kinking/bending in the extension legs.The reported events and findings from the investigation are consistent with stretched, opacification, extrusion/protrusion and deformation due to compressive stress issues.The definitive root cause could not be determined based upon available information.Labeling review: the cause of the event in question is unknown, and so the applicability of any particular portion of the ifu or other labeling is unknown.However, 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 ifu instructs on dressing technique and catheter maintenance.Therefore, the product labeling will be considered adequate.H10: g4, h6 (a040601 - deformation due to compressive stress).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.

• Brand Name: HEMOSPLIT, 14.5 FR, ST, 19CM, STAND KIT
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9818354
• MDR Text Key: 194498262
• Report Number: 3006260740-2020-00803
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741012884
• UDI-Public: (01)00801741012884
• Combination Product (y/n): N
• PMA/PMN Number: K030020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

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: 5703690
• Device Catalogue Number: 5703690
• Device Lot Number: RECP0336
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 06/25/2020
• Supplement Dates FDA Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CEFAZOLIN, HEPARIN, SALINE
• Patient Age: 77 DA