MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA DIALYSIS CATHETER KIT 13.5F X 20CM (SHORT-TERM) (DUAL-LUMEN); CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 04/17/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of recx2504 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that when checking the package prior to use, a nurse found a black hairy foreign matter in unopened package of a dialysis catheter.This catheter was not used on the patient.

Event Description

It was reported that when checking the package prior to use, a nurse found a black hairy foreign matter in unopened package of a dialysis catheter.This catheter was not used on the patient.

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 a foreign material in within the kit is confirmed and appears to be manufacturing related.One video sample of a niagra catheter kit was provided for evaluation.The video shows a section of the kit that appears to be sealed.A person is shown to be manipulating the outer surface of the packaging to show the presence of a black fiber within the kit.The fiber appears to resemble a hair.Since the video provided appears to show a hair within a sealed kit, the complaint is confirmed.The video sample will be forwarded to the manufacturing facility for further evaluation.----------------------------------------------------------------------------------------------------- reynosa evaluation complaint due to ¿black hairy foreign matter in unopened package¿ was confirmed.According with the video sample reviewed at reynosa facility the following was concluded: a foreign material (hair) was found to be deposed inside the sealed kit.That contaminant was trapped during the sealing process making the device unsafe for our customer.Therefore, the cause of this condition is manufacturing related.A lot history review (lhr) of recx2504 showed no other similar product complaint(s) from this lot number.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5F X 20CM (SHORT-TERM) (DUAL-LUMEN)
• 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: 10049915
• MDR Text Key: 191862859
• Report Number: 3006260740-2020-01721
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045578
• UDI-Public: (01)00801741045578
• Combination Product (y/n): N
• PMA/PMN Number: K030268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

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 Expiration Date: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 5593200
• Device Lot Number: RECX2504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 05/12/2020
• Supplement Dates Manufacturer Received: 05/21/2020
• Supplement Dates FDA Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1