MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number 5733730

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard 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 bard.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rezl2044 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the facility that the catheter tore an estimated two centimeters below the skin.The catheter was removed and a new one was placed.No patient harm was reported and no other information is available regarding this event.

• Brand Name: HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225964
• MDR Report Key: 6185195
• MDR Text Key: 63091847
• Report Number: 3006260740-2016-00688
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741000454
• UDI-Public: (01)00801741000454(17)171130(10)REZL2044
• Combination Product (y/n): N
• Reporter Country Code: LE
• PMA/PMN Number: K030020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 5733730
• Device Lot Number: REZL2044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization