MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA DIALYSIS CATHETER KIT 13.5F X 20CM (SHORT-TERM) (DUAL-LUMEN); CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 01/05/2023

Event Type  malfunction  

Event Description

It was reported that the doctor found that there were no graduations with the product when in use.No other information was provided.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refw0686 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in china.Device not returned for evaluation.

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: sample analysis, patient severity, applicable previous investigation(s), complaint and lot history review, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of missing depth markers is unconfirmed as the returned product was found to meet specifications.One niagara catheter kit was returned for evaluation.An initial visual observation showed the kit was returned open and use residue was observed on the components within the kit.No depth markers were observed on the catheter tubing of the catheter within the open kit, but depth markers were observed on the guidewire within the kit.While no depth markers were observed on the returned catheter, the catheter within this specific kit is not intended to have depth markers.Therefore, this complaint was unconfirmed.H3 other text: evaluation findings are in section h11.

Event Description

It was reported that the doctor found that there were no graduations with the product when in use.No other information was provided.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5F X 20CM (SHORT-TERM) (DUAL-LUMEN)
• 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 olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16260431
• MDR Text Key: 308580180
• Report Number: 3006260740-2023-00191
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045578
• UDI-Public: (01)00801741045578
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

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: 5593200
• Device Lot Number: REFW0686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 01/27/2023
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA Received: 04/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• 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