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

Catalog Number	5834190
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H11: 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.
Event or Problem Description
It was reported that a dialysis catheter placement procedure occurred on (b)(6)2024, and sometime post procedure, the external lumen of the catheter allegedly developed a small pinhole and was explanted on (b)(6)2024.Follow up details provided by the complainant on (b)(6) 2024 indicated that the patient was unknown gender, 82 y/o.The line was replaced, and the patient was subsequently discharged with no other interventions required for this incident.The device is not available for return.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one 24cm hemostar d/l catheter was returned for evaluation.Gross visual, microscopic, tactile and functional evaluations were performed.An in-house syringe was attached to the blue luer and was patent to infusion and aspiration.No leaks were observed throughout the catheter.Hydrostatic pressure was applied by clamping the distal end of the catheter while infusing to observe for leaks.A leak was observed exiting from what appeared to be pinholes that were in-parallel, at the blue luer extension leg.The catheter was placed under microscopic observation, and what appeared to be pinholes, in-parallel, were noted on the blue luer extension leg.Therefore, the investigation is confirmed for the reported material puncture issue.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.H10: g3.H11: h6 (result, conclusion).H11: 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.
Event or Problem Description
It was reported that a dialysis catheter placement procedure occurred on (b)(6) 2024, and sometime post procedure, the external lumen of the catheter allegedly developed a small pinhole and was explanted on (b)(6) 2024.Follow up details provided by the complainant on 24-dec-2024 indicated that the patient was unknown gender, 82 y/o.The line was replaced, and the patient was subsequently discharged with no other interventions required for this incident.The device is not available for return.

• 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: 21292458
• Report Number: 3006260740-2025-00276
• Device Sequence Number: 13072806
• Product Code: MSD
• UDI-Device Identifier: 00801741013430
• UDI-Public: (01)00801741013430(17)251130(10)REJN1738
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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: 11/30/2025
• Device Catalogue Number: 5834190
• Device Lot Number: REJN1738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 04/25/2025
• 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