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

Catalog Number	5833690
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a patient underwent a dialysis catheter placement procedure using the hemostar hemodialysis catheter.During the procedure, the tunneller allegedly broke off into pieces whilst on the patient.And half of the tunneller was easily removed from the surgical site.However, the other half of the metal component of the tunneller remained in site.The current status of the patient was unknown.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records will be performed.However, the return of the sample is pending.The investigation of the reported event is currently underway.Section a through f: the information provided by bd 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 bd.
Event or Problem Description
On (b)(6) 2026, a patient underwent a dialysis catheter placement procedure using the hemostar hemodialysis catheter.During the procedure, the tunneller allegedly broke off into pieces whilst on the patient.Reportedly, half of the tunneller was easily removed from the surgical site.However, the other half of the metal component of the tunneller remained in site.The current status of the patient was unknown.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one tunneler with a loaded protective sheath in two segments were received for evaluation.Visual, functional testing were performed.The protective sheath was returned in two segments, one segment was retained on the tunneler.A nearly circumferential break was noted to both ends of the protective sheath segments that appeared to fit together.The attached segment of the protective sheath terminated at the end of the barbed portion of the tunneler.A bend was noted to the tunneler.Therefore, the investigation is confirmed for the reported fracture, material separation and identified deformation.The definitive root cause could not be determined based upon available information.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) #), g3, h6 (device, component, method, result, conclusion) 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 24493967
• Report Number: 3006260740-2026-01331
• Device Sequence Number: 18795818
• Product Code: MSD
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 5833690
• Device Lot Number: REJR0428
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown