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

Catalog Number 127108D

Device Problems Crack (1135); Fluid/Blood Leak (1250); Infusion or Flow Problem (2964); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2022

Event Type  malfunction  

Event Description

Event 1: picc placed to patient for tpn (total parenteral nutrition).When clave placed on picc line hissing noted.Upon further inspection small crack noted to lumen.Lot# refx5564.Line changed with no issues.Event 2: up to place picc line.Line placed without difficulty.When clave placed and checked for blood return air noted into syringe.When flushed, saline noted dripping out between clave and hub.Claves changed out and same thing happened.Syringe directly attached to hub and same thing happened.Was on purple lumen of picc.Lot# refx5564.New picc placed to patient with no issues.Manufacturer response for picc line, power picc line (per site reporter) sequestered these lots, notified manufacturer.Waiting for the investigation.Manufacturer representative swapped out with new lot numbers.

• Brand Name: POWERPICC
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 14353690
• MDR Text Key: 291369582
• Report Number: 14353690
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 127108D
• Device Lot Number: REFY1242, REFX5564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other