MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EQUISTREAM SPLIT TIP; DIALYSIS CATHETER

Catalog Number UNK EQUISTREAM SPLIT TIP

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A photo was provided to the manufacturer for review.As the lot number for the device was not provided, a review of the device history records has not been performed.The device is not available for return.The investigation is currently underway.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 that some time post catheter placement, the catheter allegedly became white, thin, and began to bulge.The device was removed and replaced.There was no reported patient injury.

Event Description

It was reported that some time post catheter placement, the catheter allegedly became white, thin, and began to bulge.The device was removed and replaced.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a lot history record review could not be completed as the lot number was not provided.Investigation summary: although the sample was not returned for evaluation, one electronic photo was provided for review.The photo shows a dialysis catheter implanted in the patient.Only the proximal portion of the catheter shaft, the bifurcation and suture wings, the distal portion of the extension legs and clamps are visible.There appears to be a milky white color and bulging in both extension legs just proximal to the bifurcation.One of the extension legs appears to be bent or kinked.Based on the photo review, opacification, bulging and kinking of the extension legs can be confirmed.The investigation is confirmed for opacification and deformation of extension legs, as the photo review identified a milky white color, bulging and kinking 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 instructions for use (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 catheter maintenance.Therefore, the product labeling will be considered adequate.H10: g4, h6(device codes-2889).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: EQUISTREAM SPLIT TIP
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9779819
• MDR Text Key: 194127845
• Report Number: 3006260740-2020-00706
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• PMA/PMN Number: K090101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

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 Catalogue Number: UNK EQUISTREAM SPLIT TIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 03/03/2020
• 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