MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWER PORT WITH OPEN CATHATURE; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 4808060

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Reaction (2414)

Event Date 06/15/2019

Event Type  Injury  

Event Description

In (b)(6) 2018 i had a bard power port placed for regular infusions.Within a few months i developed a sensitivity to the heparin that was used at the end of each infusion every other day that was concerning enough that even with pretreatment with a histamine blocker and antihistamine my allergist still prescribed epi pens in case i developed an anaphylactic reaction.This usage of heparin caused enough localized reaction that it repeatedly formed fibrin sheaths and blood clots until a sheath formed that didn¿t respond to tpa by the middle of 2019.It was decided to replace the device and despite knowing the heparin was an issue the hospital replaced with the same model device and within a couple of months it began forming fibrin sheaths, a model that didn¿t require heparin was available but the manufacturer failed to inform the hospital or the doctors performing the port placements of the safer option called a power port with a groshong catheter.Fda safety report id # (b)(4).

• Brand Name: POWER PORT WITH OPEN CATHATURE
• Type of Device: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 9672096
• MDR Text Key: 178013635
• Report Number: MW5092774
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 4808060
• Device Lot Number: REDR0568
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 49 YR
• Patient Weight: 104