MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 20CM (STRAIGHT) (SHORT-TERM) (DUAL; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problems Nonstandard Device (1420); Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recx2877 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the indication for the 20cm clamp at the straight tip of a spare tube was wrong.It should use 1.4, but used 1.8.

Manufacturer Narrative

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 an incorrect priming volume indicated on the arterial lumen clamp was confirmed and the cause appeared to be manufacturing-related.The product returned for evaluation was one photograph which depicted a 20cm niagara acute dialysis catheter.The depicted device was implanted, with the molded joint, extension tubes and luer adapters visible.The blue clamp indicated a priming volume of 1.4ml and the red clamp indicated a priming volume of 1.8ml.The arterial lumen clamp marking indicated a priming volume of 1.8ml; however, the clamp should indicate a volume of 1.4ml per the applicable device drawing.It appeared that the device was assembled with the wrong clamp or an incorrectly marked clamp.The received photograph has been forwarded to the manufacturing site for further evaluation.Reynosa evaluation.Complaint due to ¿id tag was wrong¿ was confirmed, according with photo evaluation performed at reynosa facility and photo evaluation performed by vad field assurance it was concluded that a wrong id tag was assembled on clamp during the manufacturing process.Therefore, the cause of this condition is manufacturing related.A lot history review (lhr) of recx2877 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the indication for the 20cm clamp at the straight tip of a spare tube was wrong.It should use 1.4, but used 1.8.

• Brand Name: NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 20CM (STRAIGHT) (SHORT-TERM) (DUAL
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9282340
• MDR Text Key: 165234121
• Report Number: 3006260740-2019-03451
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045363
• UDI-Public: (01)00801741045363
• Combination Product (y/n): N
• PMA/PMN Number: K010778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5553200
• Device Lot Number: RECX2877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 DA
• Patient Weight: 66