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

Catalog Number UNKNOWN

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Cardiac Arrest (1762); Death (1802); Fever (1858)

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.

Event Description

Per elsevier inc.Study: " a 5fr double lumen power-injectable picc was chosen for the insertion.The wire advance without difficult.Dilator and picc advance easily.The entire 55-cm catheter was advanced into the patient without complications.Both lumens of the catheter aspirated blood and flushed easily.On day 2, the patient developed significant gastrointestinal bleeding and the access was used to infuse multiple units of packed red blood cells to correct the low hemoglobin level.The patient also developed fever and an increase in white blood cells." days 3, 4, 5 were spent stabilizing (p.236).Day 16 vas was paged by bedside rn and notified that the picc was completely occluded.The bedside nurses were unable to infuse of draw blood.Complete patency to the picc was restored after 2 doses of 2mg/2ml of cathflo activase were instilled into the catheter.Unfortunately, this patient suffered cardiac arrest the next day during dialysis.He was resuscitated and sent to icu.Family requested to withdraw care and the patient expired shortly after.(p.237).Reference: complex vascular access: mid-thigh femoral peripherally inserted central catheter placement constance girgenti, bsn, rn, va-bc, sheri pieroni, bsn, rn, va-bc - elsevier inc.Association for vascular access.

• 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: 8926769
• MDR Text Key: 155668465
• Report Number: 3006260740-2019-02477
• 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?: No
• 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 Age: 38 YR