MAUDE Adverse Event Report: BECTON DICKINSON AND CO. / BARD ACCESS SYSTEMS, INC. POWER PICC PROVENA; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Lot Number REFT4476

Device Problems Component Missing (2306); Obstruction of Flow (2423); Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 11/29/2021

Event Type  malfunction  

Event Description

Picc line placed on patient's left arm.When completed, the inner wire removed and this rn assessed for patency before dressing was completely secured.It was assessed that the red lumen was occluded and purple lumen was flushing well with positive blood return.This rn used 1st wire to assess red lumen by inserting it into red lumen.Occlusion was noted and felt like something stuck into catheter.Picc line removed and new one placed using sterile cath exchange technique.Upon assessing pervious picc, the inner wire was noted to be missing end copper tip part.Picc line feels like wire was jammed into catheter.Md notified of findings for possible wire fragmentation.Chest x-ray ordered.Chest x-ray did not show anything concerning.Picc line and wire placed into biohazard bag and placed into iv team managers box.Fda safety report id# (b)(4).

• Brand Name: POWER PICC PROVENA
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON AND CO. / BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 13236985
• MDR Text Key: 283767344
• Report Number: MW5106595
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: REFT4476
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female