MAUDE Adverse Event Report: MEDCOMP 4F X 20CM SINGLE LUMEN MIDLINE; INFUSION CATHETER

Model Number ML4S20

Device Problems Material Fragmentation (1261); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/26/2014

Event Type  Injury  

Event Description

Procedure commenced using ultrasound guidance, right basilic vein cannulated and guidewire threaded.At 8cm the guidewire would not thread therefore removed, 2nd attempt at threading was also unsuccessful.The guidewire would not completely pull out from the exit site.Several attempts made and registrar called to assist.He was also unsuccessful at removing the wire, x-ray of arm ordered by registrar which showed approximately 2cm fragment sat in the upper aspect of the patient's arm.Transferred to another (b)(6) for vascular surgeons to remove the fragment of wire from patient's arm without success.Approximately 2cm remain embedded in the wall of the vein and unable to be removed unless vein dissected.

Manufacturer Narrative

Received a small segment of the guidewire for evaluation.A visual examination of the piece of the guidewire revealed it is elongated and approximately 13cm in length.A review of the manufacturing records indicated that all device specifications and quality requirements were satisfied.We are unable to determine the cause or factors that may have contributed to this event.The segment of guidewire is too small and damaged for an evaluation.

• Brand Name: 4F X 20CM SINGLE LUMEN MIDLINE
• 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: 4593773
• MDR Text Key: 5632718
• Report Number: 2518902-2015-00028
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ML4S20
• Device Catalogue Number: ML4S20
• Device Lot Number: MGLC960
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2014
• 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: 50 YR
• Patient Weight: 78