MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA SLIM-CATH 15 CM PRE-CURVE KIT; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number N/A

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recn0462 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that impurities were present inside the introducer needle.No other information was provided.

Event Description

It was reported that impurities were present inside the introducer needle.No other information was provided.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of foreign material within an introducer needle is inconclusive due to poor sample condition.One15 cm niagara dialysis catheter, one clear plastic stylet, and a kit label were returned for evaluation.No introducer needle was returned for evaluation.An initial visual observation showed a white crystalline residue within the extension leg of the red lumen.A microscopic observation revealed black and red residue on the hub of the stylet and a greyish residue on the distal tip of the stylet.The introducer needle alleged in the reported event was not returned, and the samples that were returned for evaluation were returned in such a state that it could not be determined where the returned samples may have come into contact with the observed residues.Therefore, this complaint is inconclusive at this time.A lot history review (lhr) of recn0462 showed no other similar product complaint(s) from this lot number.

• Brand Name: NIAGARA SLIM-CATH 15 CM PRE-CURVE KIT
• Type of Device: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8917068
• MDR Text Key: 155199507
• Report Number: 3006260740-2019-02432
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045394
• UDI-Public: (01)00801741045394
• 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: 10/18/2019

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: 5554150
• Device Lot Number: RECN0462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 10/10/2019
• Supplement Dates FDA Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1