MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNKNOWN HEMOSTAR; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number UNKNOWN

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2017

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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

The facility reported to the sales rep that the 19cm hemostar dialysis catheter was inserted on (b)(6) 2017.Patient dialysed at home.Accessed at home.Noticed small air bubbles coming from the extension when they aspirated with a syringe.It was removed and replaced (b)(6) 2017.Nurses validated that there was an air bubble at the arterial port only.

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 leak path in the arterial lumen of the catheter was unconfirmed since the reported event could not be replicated.One 19cm hemostar catheter was returned for investigation.The catheter exhibited evidence of use.Residue was observed within the fibers of the cuff.The section of d/l tubing proximal to the cuff and the bifurcation were yellow in color.The extension legs were cloudy and the clamps were pink in color.A functional test revealed no pathway for air to enter the arterial (red) lumen.The arterial lumen was pressurized with water, but no leaks were observed.The arterial lumen was aspirated while the distal tip of the catheter was clamped, but and no air entered the syringe.When pressurizing the venous (blue) lumen, a leak was observed at the proximal end of the cuff.A microscopic examination of the leak site in the venous lumen revealed slits in the tubing.The cuff fibers were also cut over the damaged area of tubing.The breach in the tubing is consistent with sharp instrument damage that occurs during surgical removal of the cuff and catheter.Since the complainant validated that the air was only in the arterial (red) lumen and since the reported event could not be replicated, the complaint was unconfirmed.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

Facility reported to the sales rep that they had two incidents with the 19cm hemostar dialysis catheter.No other information was provided, but has been requested.It was reported that the catheter was inserted on (b)(6) 2017.Patient dialysed at home.Accessed at home.Noticed small air bubbles coming from the extension when they aspirated with a syringe.It was removed and replaced (b)(6) 2017.Nurses validated that there was an air bubble at the arterial port only.

• Brand Name: UNKNOWN HEMOSTAR
• 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: shauna nielson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225536
• MDR Report Key: 7051327
• MDR Text Key: 93454306
• Report Number: 3006260740-2017-02094
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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