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

Model Number REFERENCE: 1194108D5

Device Problems Contamination (1120); Entrapment of Device (1212); Difficult to Remove (1528); Stretched (1601); Detachment of Device or Device Component (2907); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/17/2021

Event Type  Injury  

Event Description

A picc line catheter was being removed and stopped coming out all the way.When it was pulled out, the end that was in the patient's arm came out stretched, thinner than a normal size picc, and had fibers of tissue on the end of it.Part of the catheter remained in the patient's arm.Fda safety report id # (b)(4).

• Brand Name: PICC LINE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 11412748
• MDR Text Key: 235048336
• Report Number: MW5099781
• Device Sequence Number: 1
• Product Code: LJS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REFERENCE: 1194108D5
• Device Lot Number: REEU0203
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 95