MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DUOGLIDE SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Codes	Backflow (1064); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: 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.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported nurse notified dr that hd catheter site having continuous bleeding, multiple attempts made to stop bleeding, dressing changed this am and pressure dressing applied.Dr assessed area and then dressing changed at 1400 gelfoam, pressure dressing and allevyn applied at that time.At 1600 dressing was saturated and dr at beside assessed site.It was determined that the bleeding was from the catheter not the catheter insertion site.Dr removed the hd catheter.After removal of catheter dr determined that possible vascular tissue protruding from insertion site.Pressure held at site by the rn, dr in contact with vascular surgery department at hospital.Patient vital signs remain stable, patient¿s husband at bedside and aware of plans at this time.No harm to the patient other than the procedure/pain it caused of being inserted, being of no use, and having to take it out.
Event or Problem Description
It was reported nurse notified dr that hd catheter site having continuous bleeding, multiple attempts made to stop bleeding, dressing changed this am and pressure dressing applied.Dr assessed area and then dressing changed at 1400 gelfoam, pressure dressing and allevyn applied at that time.At 1600 dressing was saturated and dr at beside assessed site.It was determined that the bleeding was from the catheter not the catheter insertion site.Dr removed the hd catheter.After removal of catheter dr determined that possible vascular tissue protruding from insertion site.Pressure held at site by the rn, dr in contact with vascular surgery department at hospital.Patient vital signs remain stable, patient¿s husband at bedside and aware of plans at this time.No harm to the patient other than the procedure/pain it caused of being inserted, being of no use, and having to take it out.
Additional Manufacturer Narrative
H11: 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.

• Brand Name: DUOGLIDE SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18767941
• Report Number: 3006260740-2024-00733
• Device Sequence Number: 7907064
• Product Code: MPB
• UDI-Device Identifier: 00801741042065
• UDI-Public: (01)00801741042065
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K030268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

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 Model Number: N/A
• Device Catalogue Number: 5624150
• Device Lot Number: UNKNOWN
• 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: 01/30/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown