MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 2.6F X 50CM DUAL LUMEN PICC; VASCU-PICC

Model Number	MR17012601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.
Event or Problem Description
Hospital reports the radiology technician was bedside re-taping the nasal cannula.The baby was crying and kicking his legs.Nurse went to help and noticed the 2.6f vascu-picc was broken at the hub and lying in the bed.The rest of the catheter was removed and a new peripheral iv was placed.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation (lost in transit).No photos were provided.Attempts to obtain additional information about the device and event and to have the sample returned for evaluation were unsuccessful.A review of the manufacturing records was not possible as the lot number of the device was not provided.The report indicated the catheter was inserted in the baby's leg and the baby was crying and kicking his legs.This may have contributed to the lumen breakage.Without an evaluation of the device involved we are unable to determine the exact cause of the reported failure.

• Brand Name: 2.6F X 50CM DUAL LUMEN PICC
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9621488
• Report Number: 2518902-2020-00003
• Device Sequence Number: 1965486
• Product Code: LJS
• UDI-Device Identifier: 00884908085693
• UDI-Public: 884908085693
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

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: MR17012601
• Device Catalogue Number: MR17012601
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 03/18/2020
• 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