MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNKNOWN DIALYSIS; DIALYSIS CATHETER

Catalog Number UNK DIALYSIS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Thrombosis/Thrombus (4440)

Event Date 12/27/2023

Event Type  Injury  

Event Description

It was reported in an article that sometime post a dialysis catheter placement, of forty-five patients, fifteen patients were allegedly developed with infection where the organism of infection was either gram negative bacilli, klebsiella, pseudomonas, methicillin resistant staphylococcus aureus, citrobacter, acinetobacter, or candida glabra.It was further reported that of forty-five patients, thirteen patients were allegedly diagnosed with thrombosis.Reportedly, the infections were treated with either antibiotics or catheter removal and thrombosis were treated with either urokinase locking solutions, recombinant-urokinase infusions, or catheter removal.The current status of the patients is unknown.

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: section a through f ¿ the information provided by bd represents all 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.H3 other text : device not returned.

• Brand Name: UNKNOWN DIALYSIS
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18573953
• MDR Text Key: 333629170
• Report Number: 3006260740-2024-00172
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK DIALYSIS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention