MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. MINILOC SAFETY INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION INTRAVASCULAR

Lot Number ASDRF027

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2019

Event Type  malfunction  

Event Description

Describe event, problem, or product use error: 1000.Pt called from bathroom and states his "port came out." came in to assess same and noted that night port had pulled apart at y-site before lumens.Unable to clamp tubing due to same.Rt port needle and dressing still intact.Pt had just gotten out of shower at this time and states he is unaware of how this happened as he does not remember pulling on same.Pt lied down in bed, de-accessed and re-accessed port without incident.Dr (b)(6) made aware of incident as well as picc team.Will continue to monitor same.

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 0.75IN
• Type of Device: SET, ADMINISTRATION INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 8931166
• MDR Text Key: 155692627
• Report Number: MW5089302
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: ASDRF027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR