MAUDE Adverse Event Report: C.R. BARD INC. BARD; POWER PORT

Lot Number REZL2389

Device Problems Defective Device (2588); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

Defective product, removed by another facility, tubing dislodged from the power port.Product explanted at another facility, unsure of date that product was explanted.

• Brand Name: BARD
• Type of Device: POWER PORT
• Manufacturer (Section D): C.R. BARD INC.
• MDR Report Key: 6666596
• MDR Text Key: 78465371
• Report Number: MW5070602
• Device Sequence Number: 1
• Product Code: LJT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2020
• Device Lot Number: REZL2389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• 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): Other