MAUDE Adverse Event Report: MEDCOMP 5F DUAL VASCU-PICC; INFUSION CATHETER

Model Number MR17015206

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 08/30/2014

Event Type  Injury  

Event Description

Staff nurse noted swelling to the extremity where the picc line was inserted.The picc line was removed and an ultrasound was ordered by the md.Ultrasound reveals that there is no evidence of thrombosis in the left upper extremity.

Manufacturer Narrative

An investigation has been initiated.When the investigation is complete a supplemental report will be submitted.

• Brand Name: 5F DUAL VASCU-PICC
• Type of Device: INFUSION CATHETER
• Manufacturer (Section D): MEDCOMP; harleysville PA
• Manufacturer (Section G): MEDCOMP; 1499 delp dr.; harleysville PA 19438
• Manufacturer Contact: susan smith, rn ; 1499 delp dr.; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 4142704
• MDR Text Key: 4911771
• Report Number: 2518902-2014-00064
• Device Sequence Number: 1
• Product Code: JCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2016
• Device Model Number: MR17015206
• Device Catalogue Number: MR17015206
• Device Lot Number: MBSX660
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2014
• Date Device Manufactured: 03/28/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 64