MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HemoStar; Dialysis Catheter

Catalog Number	5833730
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hypovolemic Shock (1917)
Date of Event	12/15/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records will 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.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.
Event or Problem Description
On (b)(6) 2024, a patient underwent catheterization into the right internal jugular vein using the hemostar hemodialysis catheter.On (b)(6) 2024, the patient experienced a rupture of the dialysis catheter while at home.Emergency responders applied pressure to the tubing and transferred the patient to the hospital and diagnosed with acute respiratory failure and hemorrhagic shock.The patient went into cardiac arrest and cpr was performed.Despite resuscitation efforts, the patient subsequently expired.
Event or Problem Description
On (b)(6) 2024, a patient underwent catheterization into the right internal jugular vein using the hemostar hemodialysis catheter.On (b)(6) 2024, the patient experienced a rupture of the dialysis catheter while at home.Emergency responders applied pressure to the tubing and transferred the patient to the hospital and diagnosed with acute respiratory failure and hemorrhagic shock.The patient went into cardiac arrest and cpr was performed.Despite resuscitation efforts, the patient subsequently expired.
Additional Manufacturer Narrative
H11: manufacturing review: device history records have been reviewed for lot rehv1354, confirming that applicable manufacturing, sub-assembly, component, and inspection activities were completed in accordance with requirements and that the lot met release criteria, with no deviations, nonconformances, or adverse trends identified.There is no evidence to suggest the reported complaint is attributable to manufacturing or material-related causes.Investigation summary: the device was not returned for evaluation, and no medical records or photographic evidence were provided.Therefore, the investigation is limited to the information reported and remains inconclusive with respect to the reported breakage, blood leakage, and resulting patient consequences, including significant blood loss, cardiac arrest, and death.Based on the absence of objective supporting evidence and the limitations of the available information, a definitive root cause cannot be determined.Labeling review: as the reported event did not allege a labeling or use related issue a labeling review is not required.D4 (unique identifier (udi) #), e1, g3, h6 (device, method).Section a through f: the information provide 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.

• Brand Name: HemoStar
• Common Device Name: 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 25390370
• Report Number: 3006260740-2026-03890
• Device Sequence Number: 10672241
• Product Code: MSD
• UDI-Device Identifier: 00801741013409
• UDI-Public: (01)00801741013409(11)230901(17)250531(10)REHV1354
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: 5833730
• Device Lot Number: REHV1354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Supplement Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown