MAUDE Adverse Event Report: ACCESS VASCULAR, INC. HYDROPICC; PERIPHERALLY INSERTED CENTRAL CATHETER

Device Problem Material Integrity Problem (2978)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/16/2020

Event Type  malfunction  

Manufacturer Narrative

The clinician reported that on (b)(6) 2020, the hydropicc was removed, and "pt underwent a successful rewire for a new 4fr sl power picc(41cm)", and was subsequently dischared home.

Event Description

The clinician reported that the "patient was admitted to the hospital with altered mental status and found to have acute toxic metabolic encephalopathy due to severe sepsis secondary to group b strep bacteremia".On the same date, the patient made a visit to the ir suite to have the picc evaluated, where it was noted that "on initial assessment, patient alert and appears in no distress, lying in her bed.The picc insertion site w/o s/sx of infection, wetness noted under the dressing but the dressing boarder is intact.Blood noted in picc line near insertion site." it was further reported that ".After dressing changed sl picc line flushed with ns and immediately noted saline leaking at insertion site under the dressing followed by pink tinged fluid leaking from the insertion site.".

• Brand Name: HYDROPICC
• Type of Device: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ACCESS VASCULAR, INC.; 175 middlesex turnpike; suite 1a; bedford, ma
• MDR Report Key: 10145394
• MDR Text Key: 200852173
• Report Number: 3015060232-2020-00003
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Date Manufacturer Received: 05/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CEFTRIAXONE 2G Q24 HOURS
• Patient Outcome(s): Other
• Patient Age: 73 YR