MAUDE Adverse Event Report: MEDCOMP 2.6F X 50CM DUAL VASCU-PICC; VASCU-PICC INFUSION CATHETER

Model Number	MRVSP26001
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.Additional information and the return of the sample for evaluation have been requested.When the investigation is completed a supplemental report will be submitted.
Event or Problem Description
The device broke post placement.
Additional Manufacturer Narrative
There was no visible damage to the luers, clamps, extensions or hub.The lumen was trimmed at the 23cm mark.The lumen is separated from the hub.The end of the lumen which remains inside the hub appears to have been pulled.All dimensional measurements were found within specification.The kind of damage presented is not related to the manufacturing processes.The product was in use it is likely that agents external to the manufacturing process may have caused the damage reported by the customer.The incident report indicated the patient was being held by family and was moving around when the line broke.
Event or Problem Description
Patient held by family members and while moving around and being handled the line broke at the catheter and wing connection.No harm to patient.Line removed and replaced.

• Brand Name: 2.6F X 50CM DUAL VASCU-PICC
• Common Device Name: VASCU-PICC INFUSION CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6394488
• Report Number: 2518902-2017-00009
• Device Sequence Number: 13652712
• Product Code: LJS
• UDI-Device Identifier: 00884908125108
• UDI-Public: 884908125108
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 07/22/2019
• Device Model Number: MRVSP26001
• Device Catalogue Number: MRVSP26001
• Device Lot Number: MHRY190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Initial Date Received by Manufacturer: 02/08/2017
• Supplement Date Received by Manufacturer: 02/08/2017
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1