MAUDE Adverse Event Report: BARD ACCESS SYSTEMS IMPLANTED PERCUTANEOUS CATHETER; CATHETER, PERCUTANEOUS

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Type  malfunction  

Manufacturer Narrative

The device(s) has not been received by the manufacturer for evaluation.A lot history review (lhr) review is not possible; as no manufacturing lot number(s) has been provided.Per 21 cfr part 803.56 not enough information has been provided about each identified patient and/or device mentioned.Therefore, one emdr is being submitted for multiple reportable events, identified in the literature search.

Event Description

Per society for vascular surgery study: "a variety of catheter configurations from single manufacturer source.These procedures were performed with ultrasound guidance (two brands).54 - dvt picc vein insertion site, basilic & brachial, 42 - svt picc vein insertion site, basilic & cephalic" (p.763).Reference: peripherally inserted central catheter usage patterns and associated symptomatic upper extremity venous thrombosis.Liem tk, yanit ke, moseley se, landry gj, deloughery tg, rumwell ca, mitchell el, moneta gl.

• Brand Name: IMPLANTED PERCUTANEOUS CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 8927241
• MDR Text Key: 155553864
• Report Number: 3006260740-2019-02484
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/01/2019
• 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
• Patient Outcome(s): Required Intervention