MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA DIALYSIS CATHETER KIT 13.5FX20CM PRE-CURVED SHORT-TERM DL; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refq0948 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported a catheter is placed with the need for emergency hemodialysis, performing the procedure with the seldinger technique, without complications or adverse events at that time, in the left internal jugular vein, however, when connected to the hemodialysis machine, blood leakage is observed in the venous lumen.It was stated the catheter was replaced.

Event Description

It was reported a catheter is placed with the need for emergency hemodialysis, performing the procedure with the seldinger technique, without complications or adverse events at that time, in the left internal jugular vein, however, when connected to the hemodialysis machine, blood leakage is observed in the venous lumen.It was stated the catheter was 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.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking dialysis catheter was confirmed.The product returned for evaluation was one 20cm niagara d/l pre-curved dialysis catheter.Usage residues were observed throughout the sample.An irregular, longitudinally aligned split was observed at the distal end of the blue-luered extension tube.Microscopic inspection of the split revealed a coarsely striated fracture surface.Material flow was observed throughout the fracture region.Surface material abrasion was observed in the vicinity of the split.An attempt to infuse water through the sample using a 12ml syringe revealed both lumens to be patent to infusion; however, when flushing the blue-luered lumen, a spraying leak was observed emanating from split.The split features, material flow and surface abrasion were consistent with damage caused by manipulation of the catheter using a traumatic instrument(s) such as forceps or hemostats.H3 other text : evaluation findings are in section h.11.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5FX20CM PRE-CURVED SHORT-TERM 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12685421
• MDR Text Key: 278093212
• Report Number: 3006260740-2021-04489
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K030268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 5594200
• Device Lot Number: REFQ0948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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