MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 2.6F X 50CM DUAL VASCU-PICC; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number MD17012601

Device Problems Crack (1135); Flushing Problem (1252)

Patient Problem Insufficient Information (4580)

Event Date 03/05/2021

Event Type  malfunction  

Event Description

Placed peripherally inserted central catheter (picc).X-ray obtained.Pulled back picc catheter and catheter unable to flush.Removed picc line and picc was found to be cracked.After insertion of line, on attempt to flush, met resistance, after troubleshooting, line was pulled and there was a crack in the line.Easily identified, just over 2cm from the cut tip of the catheter.This event had minimal temporary harm.

• Brand Name: 2.6F X 50CM DUAL VASCU-PICC
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 11640571
• MDR Text Key: 244711468
• Report Number: 11640571
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MD17012601
• Device Catalogue Number: MD17012601
• Device Lot Number: MPFF010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 DA