MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EQUISTREAM XK LONG-TERM HEMODIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number 6913230

Device Problem Torn Material (3024)

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

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 for evaluation.A lot history review (lhr) of reay1182 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that a new catheter was torn during ct scan injection (more info to be obtained).No patient injury 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 tear in the catheter was confirmed, and the cause was determined to be use related.The external segment of a 23cm equistream xk was returned for investigation.The d/l tubing had been cut 7mm distal to the bifurcation and the distal segment of catheter was not returned for investigation.Adhesive residue from what was most likely a dressing was observed on the extension legs, bifurcation, and d/l tubing.A 2.1cm longitudinal split was observed in the extension leg with the blue luer adaptor.The extension leg exhibited deformation from ballooning along the length of the split, which is indicative of overpressurization.The dimensions of the extension leg distal to the split were within specification.No damage or defects related to the manufacturing process were observed on the catheter.The ifu indicates that infusion pressures must not exceed 25 psi (172 kpa).The use of a 10 ml or larger syringe is recommended because smaller syringes generate more pressure than larger syringes.

Event Description

It was reported that a new catheter was torn during ct scan injection (more info to be obtained).No patient injury reported.

• Brand Name: EQUISTREAM XK LONG-TERM HEMODIALYSIS CATHETER
• 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6583486
• MDR Text Key: 75815958
• Report Number: 3006260740-2017-00667
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741121753
• UDI-Public: (01)00801741121753(17)181031(10)REAY1182
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K090101
• 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: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 6913230
• Device Lot Number: REAY1182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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