MAUDE Adverse Event Report:; MICRO-INTRODUCER KIT

Model Number 7CM INTRODUCER, 50CM NITIONAL WIRE.

Device Problem Device Slipped (1584)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/15/2015

Event Type  Injury  

Event Description

A right umbilical artery (rua) picc was placed on patient.The insertion site kept oozing blood.We held external pressure on the patient's arm but the site continued to ooze blood.The patient's dressing and pillow underneath the arm was saturated with blood.We removed the dressing, cleaned the site with chlorhexidine, and applied surgicel.During removal of the dressing, there was a small visible clot at site but the picc line slide out of patient when everything was removed because the site was so saturated.We called the picc team and was advised to put another surgicel at site and place a pressure dressing on arm and to not remove picc line.

• Type of Device: MICRO-INTRODUCER KIT
• MDR Report Key: 4833428
• MDR Text Key: 17307512
• Report Number: 4833428
• Device Sequence Number: 1
• Product Code: DYB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 7CM INTRODUCER, 50CM NITIONAL WIRE.
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/14/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR