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

Catalog Number	5903230
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Air/Gas in Device (4062)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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
On (b)(6) 2025, a patient underwent for a dialysis catheter implant using equistream split tip via jugular to right atrium, the valve was broken on air guard devices.Further, air embolism was found via peel away sheath.Patient went home post observation.Procedure was completed normally.Current status of patient is unknown.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one 15.0fr partially peeled peel-apart sheath and one dilator were returned for evaluation.Visual and functional evaluations were performed on the returned device.The peel-apart sheath was not fully peeled as only one side of the sheath shaft was sliced opened.No anomalies were noted to both ends of the devices.The investigation is inconclusive for the reported valve fracture, material separation and air in device issues as the returned sample was not in not in proper condition to test for the reported issues and no anomalies were noted to both ends of the device.A definitive root cause could not be determined based upon the provided 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) #), g2, g3, h6 (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
On (b)(6) 2025, a patient underwent for a dialysis catheter implant using equistream split tip via jugular to right atrium.During the procedure, it was reported that the valve was broken on air guard devices.It was further reported that, air embolism was found via peel away sheath.The patient went home post observation.Procedure was completed normally.The current status of patient is unknown.

• Brand Name: EQUISTREAM SPLIT TIP
• 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: 22504535
• Report Number: 3006260740-2025-04814
• Device Sequence Number: 13073187
• Product Code: MSD
• UDI-Device Identifier: 00801741013706
• UDI-Public: (01)00801741013706(11)240322(17)251231(10)REJP1203
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K090101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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: 12/31/2025
• Device Catalogue Number: 5903230
• Device Lot Number: REJP1203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2024
• 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