MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT CATHETER - STRAIGHT, POLYURETHANE CATHETER; DIALYSIS CATHETER

Model Number 5743690

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was not provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.

Event Description

It was reported that approximately seven months post port placement, the leak was allegedly identified in the connection of the catheter.It was further reported that the catheter was removed and replaced with a new one.There was no reported patient injury.

Event Description

It was reported that approximately seven months post port placement, the leak was allegedly identified in the connection of the catheter.It was further reported that the catheter was removed and replaced with a new one.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged leak as no objective evidence has been provided to confirm any alleged deficiency with the catheter.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Possible contributing factors include over-pressurization, sharp instrument damage, and damaged during implantation; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).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.

• Brand Name: HEMOSPLIT CATHETER - STRAIGHT, POLYURETHANE CATHETER
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8273888
• MDR Text Key: 133972367
• Report Number: 3006260740-2019-00076
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013263
• UDI-Public: (01)00801741013263
• Combination Product (y/n): N
• PMA/PMN Number: K030020
• 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: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5743690
• Device Catalogue Number: 5743690
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1