MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (19CM); CATHETER, HEMODIALYSIS, IMPLANTED

Model Number 5833690

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 12/21/2017

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard 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 bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reax0592 showed no other similar product complaint(s) from this lot number.Device not returned yet.

Event Description

It was reported that after opening the package, the needle in it was found to be rusty.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a rusted tunneler was confirmed, but the exact cause was not determined due to the condition of the returned sample.One open hemostar kit was returned for investigation.The label on the external surface of the package was stained orange.Black smudges were observed on the label.The adhesive dressings were missing from the tray.The 18g introducer needle revealed no discoloration or corrosion on the external surface of the needle cannula.The external surface of the tunneler revealed a reddish orange discoloration.A similar discoloration was observed on sections of the guidewire, which had been partially removed from its hoop.Some of the discolored material was scraped from the tunneler, which revealed pitting in the tunneler.It appears that the kit and components were exposed to high humidity, but it is unknown where or when the humidity was introduced into the tray.Tyvek is not a humidity barrier.Tyvek is a breathable substrate and is designed to allow air/humidity to pass through.The label on the package states, ¿sterilized using ethylene oxide.Do not resterilize.¿ since the package was received open and no breaches in the sterile barrier were observed, the cause was not determined.A lot history review (lhr) of reax0592 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that after opening the package, the needle in it was found to be rusty.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (19CM)
• Type of Device: CATHETER, HEMODIALYSIS, 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: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7183174
• MDR Text Key: 97079882
• Report Number: 3006260740-2018-00007
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013386
• UDI-Public: (01)00801741013386
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5833690
• Device Catalogue Number: 5833690
• Device Lot Number: REAX0592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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