MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA SLIM-CATH PRE-CURVED DUAL-LUMEN DIALYSIS KIT 12F X 15CM; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number N/A

Device Problems Material Perforation (2205); Device Damaged by Another Device (2915)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s) and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged catheter is confirmed and appears to be related to the use of the device.One introducer was returned within a catheter.The introducer needle was observed to be penetrating the mid-section of the catheter.The needle was removed from the catheter.Residual material was present within the catheter and on the surface of the needle shaft.The material was observed to be tacky and have a tan color.Microscopic observation of the needle bevel revealed no apparent issues.Based on the condition of the returned sample, the catheter was likely damaged due to retraction and advancement of the needle through the catheter during handling.A lot history review (lhr) of recv2906 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that when the package was opened, it was noticed that the inner needle of the introducer needle (= iv catheter and inner needle set) had perforated the iv catheter, and the iv catheter was damaged.There was no reported patient involvement.

• Brand Name: NIAGARA SLIM-CATH PRE-CURVED DUAL-LUMEN DIALYSIS KIT 12F X 15CM
• Type of Device: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 8947305
• MDR Text Key: 156273802
• Report Number: 3006260740-2019-02547
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045332
• UDI-Public: (01)00801741045332
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: 801(E)
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2019

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: 5504150
• Device Lot Number: RECV2906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2018
• 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