MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT® 19 CM MI KIT, 19 CM TIP TO CUFF STRAIGHT; DIALYSIS

Model Number 5733690

Device Problem Failure to Infuse (2340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.( expiration date: 07/2019).

Event Description

It was reported that the catheter was allegedly occluded.No further information was provided.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: two 14.5 fr d/l hemosplit 19 cm str hemodialysis catheters with surecuff was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed.The investigation is unconfirmed for catheter occlusion, as the sample elements of both devices were separately patent to infusion and aspiration and no leaks were observed.The definitive root cause could not be determined based upon available information.It is unknown if clinical or manufacturing procedures 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.(expiry date 07/2019).

Event Description

It was reported that the catheter was allegedly occluded.It was further reported that the device was removed and replaced with a new one.There was no reported patient injury.

• Brand Name: HEMOSPLIT® 19 CM MI KIT, 19 CM TIP TO CUFF STRAIGHT
• Type of Device: DIALYSIS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8289846
• MDR Text Key: 134504338
• Report Number: 3006260740-2019-00119
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013096
• UDI-Public: (01)00801741013096
• 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: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5733690
• Device Catalogue Number: 5733690
• Device Lot Number: REBY0720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Date Manufacturer Received: 04/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1