MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD NIAGARA DIALYSIS CATHETER; 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 06/25/2023

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 for evaluation.

Event Description

Customer reported that when the nurse measured the blood glucose of the patient, there was no anomaly in the transfusion and the indwelling needle was in good condition.When the nurse of the responsibility group took over the afternoon and measured the patient's blood pressure at 14:10, it was found that the heparin cap of the patient's indwelling needle had been separated from the indwelling needle, the two liquid needles for infusion at the end of the heparin cap had fallen off, and blood was seen flowing from the bed sheet and the arm of the puncture side with the infusion liquid.The department reported that the heparin cap interface of this indwelling needle was generally loose.No other information provided.

Event Description

Customer reported that when the nurse measured the blood glucose of the patient, there was no anomaly in the transfusion and the indwelling needle was in good condition.When the nurse of the responsibility group took over the afternoon and measured the patient's blood pressure at 14:10, it was found that the heparin cap of the patient's indwelling needle had been separated from the indwelling needle, the two liquid needles for infusion at the end of the heparin cap had fallen off, and blood was seen flowing from the bed sheet and the arm of the puncture side with the infusion liquid.The department reported that the heparin cap interface of this indwelling needle was generally loose.No other information provided.

Manufacturer Narrative

H11: the initial complaint appeared to involve a bd manufactured device.After receiving additional information from the complainant, it was determined that it is not a bd manufactured device.

• Brand Name: BARD NIAGARA 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17363976
• MDR Text Key: 319833926
• Report Number: 3006260740-2023-03082
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2023
• 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