MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER WITH PRELOADED STYLET 14.5F STANDARD; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number N/A

Device Problems Air Leak (1008); Hole In Material (1293)

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

Event Date 08/07/2017

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 reav2063 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the air alarm (microbubles) came from the machine and it was thought the source of it was the catheter.Catheter was removed and a new one was placed.It was found that there was a small leakage/hole in the catheter by the hub.No patient harm was reported.

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 in the catheter was confirmed and the cause appears to be an inadvertent puncture with a sharp instrument.The proximal segment of a 23cm equistream catheter was returned for investigation.The catheter had been cut 0.5cm distal to the cuff and the distal catheter segment was not returned for investigation.The catheter exhibited evidence of use.Residue was embedded within the cuff fibers.The bifurcation was discolored yellow.The extension legs exhibit deformation from clamping.Debris was observed on the clamps and the connectors.A functional test of the catheter confirmed a leak 0.5mm distal to the molded bifurcation when the venous lumen was pressurized with water.The leak site revealed a chevron shaped slit in the tubing just distal to the bifurcation.Sharp edges were observed along the length of the slit, which is consistent with sharp instrument damage.Due to the condition of the returned catheter, it appeared that the device was damaged while in use.A lot history review (lhr) of reav2063 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the air alarm (microbubbles) came from the machine and it was thought the source of it was the catheter.Catheter was removed and a new one was placed.It was found that there was a small leakage/hole in the catheter by the hub.No patient harm was reported.

• Brand Name: EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER WITH PRELOADED STYLET 14.5F STANDARD
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6961864
• MDR Text Key: 90672829
• Report Number: 3006260740-2017-01859
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741121654
• UDI-Public: (01)00801741121654
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K090101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• 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: 6903230
• Device Lot Number: REAV2063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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