MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 20CM (STRAIGHT) (ST) (DL); CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/11/2023

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.H3 other text : device not returned.

Event Description

It was reported by customer that the vascath was put in patient's internal jugular vein c sutured in there.The two clamps on two lumens were close.Within 15 min the clamps cut through the lumen leading to bleeding.The vascath was removed.Response received 08 aug 2023: event led to bleeding which was noticed and immediately controlled.It interrupted the surgery patient was having and caused some delay but no patient harm.Vascath was removed and replaced.

Event Description

It was reported by customer that the vascath was put in patient's internal jugular vein c sutured in there.The two clamps on two lumens were close.Within 15 min the clamps cut through the lumen leading to bleeding.The vascath was removed.Response received 08 aug 2023 event led to bleeding which was noticed and immediately controlled.It interrupted the surgery patient was having and caused some delay but no patient harm.Vascath was removed and replaced.

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.Based on a review of applicable information, the following was concluded: the complaint of damaged extension tubing is confirmed; however, the root cause could not be determined.The product returned for evaluation was a 20 cm niagara slimcath acute dialysis catheter.Use residue was visible throughout the device.There was a complete break in the arterial lumen extension tubing.A circumferential aligned split was observed in the venous extension tubing.Microscopic inspection of both the complete break and partial split revealed granular fracture surfaces.Superficial stress fractures were observed in the vicinity of both the break and the split.Additionally, the extension tubes exhibited elliptical cross sections at the break and split sites.The shapes of the extension tubes near the break/split sites suggested that compression force, such as that applied by the clamps, contributed; however, the stress fractures suggested that an additional unidentified factor(s) also contributed.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h.11.

• Brand Name: NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 20CM (STRAIGHT) (ST) (DL)
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17599111
• MDR Text Key: 321689617
• Report Number: 3006260740-2023-03634
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045363
• UDI-Public: (01)00801741045363
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K010778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

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: 5553200
• Device Lot Number: REGW1880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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