MAUDE Adverse Event Report: MEDCOMP 3F X 5CM TEARAWAY INTRO SET

Model Number	MR190300
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	05/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Received a.018" guidewire for evaluation.A visual inspection revealed the guidewire to have knot about 1 cm from the tip.The guidewire was forwarded to the device contract manufacturer for evaluation.
Event or Problem Description
Attempting to place 2.6f picc to left upper arm using 3f mst kit but could not advance guidewire.On second attempt the guidewire became stuck in the baby's arm.Operator assumed the patient was having vasospasm so she massaged the arm and waited a few minutes but the wire still felt stuck.Physician was called to bedside to assess; he performed a skin nick to pull the knotted wire out.Patient was in no distress at any point in the procedure.
Additional Manufacturer Narrative
Based on the investigation, the root cause was unable to be determined.Contributing factors to the event may have been the repeated attempts at insertion and removal causing the wire to prolapse, resistance in the guidewire during insertion and the patient's anatomy.

• Brand Name: 3F X 5CM TEARAWAY INTRO SET
• Common Device Name: TEARAWAY INTRO SET
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6658249
• Report Number: 2518902-2017-00027
• Device Sequence Number: 13732089
• Product Code: DYB
• UDI-Device Identifier: 00884908093728
• UDI-Public: 884908093728
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: MR190300
• Device Catalogue Number: MR190300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 05/24/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 3