MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PPICC SOLO 4FR S/L, 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

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

Patient Problems Tachycardia (2095); Anxiety (2328); Reaction (2414)

Event Date 06/12/2018

Event Type  Injury  

Manufacturer Narrative

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

It was reported that on insertion of dialator/peel away sheath combination, pt complained of "feeling funny".As picc advanced through peel away, symptoms (unease, anxiety) worsening so picc removed (picc tip had only reached approx axilla).Issues not subsiding after removal- deranged vitals- hypertensive and tachycardic, nil chest pain- breaching met call parameters.Met team attended and mild intervention required (clinician unsure of what was administered).Remained in insertion location for approx 45mins before returning to ward.Pt did not have a reinsertion of line.Clinician believes treatment was completed with pivc.Anecdotal information- mentioned during workshop.

• Brand Name: PPICC SOLO 4FR S/L, 3CG
• 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: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 10214350
• MDR Text Key: 197291972
• Report Number: 3006260740-2020-02278
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741112249
• UDI-Public: (01)00801741112249
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 22194118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/11/2020
• 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