MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNK PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Pain (1994); Respiratory Distress (2045); Discomfort (2330); Palpitations (2467)

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.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

The patient reported the following : "the third picc line caused me intense pressure and difficulty breathing upon its insertion as well.I told the picc line nurse who told me that it was not possible.At this point, i was getting tired of being told that the pain i had been experiencing was not happening.It was! i again used the picc line for my meds, trying to cope with the pain, as it worsened.I was getting jolting stabs of lightning like pain through my heart/left chest, along with periods of intense rapid heartbeat and palpitations.I was pinned to my bed with the pain and pressure.I never had a heart attack but i think it felt like i was having one.Note: i have never had a ventricular tach, but after the second picc line was inserted, i was diagnosed with it in the hospital.I believe it continued with the third picc line as well although i was not diagnosed as such as i was at home.Finally, my doctor had me again to er where they pulled the picc line out 1 centimeter, and although i told them it was causing me intense pressure and difficulty breathing along with my ongoing chest pain, they said it was not possible, that it would improve as some time passed anyway.So, i went home, and it got much worse, to the point that i was jumping one inch off the bed when i got the intense stabbing jolts of severe pain searing the left side of my chest, the side the picc line was on at that point.I also was getting severe palpitations and jumping in my chest, seemed like my hears was racing.There was no way i could control the pain so i suffered beyond belief.I told my infusion nurses that this was occurring and they looked at me the way everyone else had been looking at me, as if i was a total nut.Upon taking the picc line out, all my symptoms were relieved." this report addresses the third picc line, the two other picc lines were reported in two previous reports.

• Brand Name: UNK PICC
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7481746
• MDR Text Key: 107189205
• Report Number: 3006260740-2018-00877
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• 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
• Patient Outcome(s): Other