MAUDE Adverse Event Report: BARD ACCESS SYSTEMS IMPLANTED TRIPLE LUMEN DIALYSIS CATHETER; CATHETER, HEMODIALYSIS, TRIPLE-LUMEN, NON IMPLANTED

Catalog Number UNKNOWN

Device Problems Kinked (1339); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Type  Injury  

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, as the device was discarded after the event occurred.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

Per sales representative, facility contact reported that a physician was placing a trialysis and dictated that the wire fed easily but the catheter would not go in.Physician tried to remove the wire but it would not come out easily.The physician was able to remove via dissection through the fat and retract the wire slowly.Physician reported to contact that the wire had kinked.A 30 cm 13 fr trialysis catheter was then inserted ok.

• Brand Name: IMPLANTED TRIPLE LUMEN DIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, TRIPLE-LUMEN, NON 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: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 5464755
• MDR Text Key: 39201489
• Report Number: 3006260740-2016-00059
• Device Sequence Number: 1
• Product Code: NIE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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