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

Catalog Number	5833730
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.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 was prepped for a dialysis catheter placement procedure using the hemostar device.Prior to the procedure, during preparation and while the packaging remained unopened, an unknown liquid was observed inside the catheter.There was no patient contact.
Event or Problem Description
On (b)(6) 2026, a patient was prepped for a dialysis catheter placement procedure using the hemostar device.Prior to the procedure, during preparation and while the packaging remained unopened, an unknown liquid was observed inside the catheter.There was no patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.Two photos were provided for review.The first photo shows the sealed packaging kit in which some kit components are noted with a leaflet of ifu of hemodialysis catheters.Kit components are not clearly identified as the picture is unclear.The second photo shows the label in which product details was mentioned and verified with tw details.The image is not clear to determine if an unknown liquid is placed inside.The investigation is inconclusive for the reported device contamination with chemical or other material issue as exact circumstances of the reported event cannot be verified from photos.The definitive root cause could not be determined based upon available information.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G2, g3, h6 (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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 24762518
• Report Number: 3006260740-2026-02213
• Device Sequence Number: 9299305
• Product Code: MSD
• UDI-Device Identifier: 00801741013409
• UDI-Public: (01)00801741013409(17)270228(10)REKR2544
• 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,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5833730
• Device Lot Number: REKR2544
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2026
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 04/13/2026; 09/22/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/16/2026; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown