MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BREVIA DIALYSIS CATHETER KIT 11F (SHORT-TERM) (24CM); CATHETER, SUBCLAVIAN

Model Number 5563240

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 recn3114 showed no other similar product complaint(s) from this lot number.

Event Description

The facility reported that the brevia catheter was fractured near the bifurcation and began leaking.No other information was provided.

• Brand Name: BREVIA DIALYSIS CATHETER KIT 11F (SHORT-TERM) (24CM)
• Type of Device: CATHETER, SUBCLAVIAN
• 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: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7664862
• MDR Text Key: 113558389
• Report Number: 3006260740-2018-01647
• Device Sequence Number: 1
• Product Code: LFJ
• UDI-Device Identifier: 00801741045448
• UDI-Public: (01)00801741045448
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K881743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5563240
• Device Catalogue Number: 5563240
• Device Lot Number: RECN3114
• 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: 01/01/2018
• 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