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

Catalog Number	5833730
Medical Device Problem Codes	Stretched (1601); Deformation Due to Compressive Stress (2889); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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, photos were provided for review.The investigation of the reported event is currently underway.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.
Event or Problem Description
It was reported that five months and twelve days post catheter placement procedure, the arterial end of the semi-permanent tube was found to be abnormally bulging.Catheter was removed and replaced due to the risk of fracture.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical sample was not returned for evaluation.One photo was provided for review.Slight bulging was noted near the clamps; a kink was noted near the proximal end of the arterial extension leg.Therefore, the investigation is confirmed for the reported stretched, material protrusion/extrusion and the identified deformation due to compressive stress.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.D4 (unique identifier (udi) #), g3, h4, h6 (device, component, method, result, conclusion) 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
It was reported that five months and twelve days post catheter placement procedure, the arterial end of the semi-permanent tube was found to be abnormally bulging.Catheter was removed and replaced due to the risk of fracture.There was no reported patient injury.

• 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: 21795919
• Report Number: 3006260740-2025-02128
• Device Sequence Number: 12824292
• Product Code: MSD
• UDI-Device Identifier: 00801741013409
• UDI-Public: (01)00801741013409(11)240430(17)260228(10)REJQ2098
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 5833730
• Device Lot Number: REJQ2098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown