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

Device Problems Backflow (1064); Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/06/2024

Event Type  malfunction  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 336977821
• Report Number: 3006260740-2024-00733
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other