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

Model Number	MR17012601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Extravasation (1842); Swelling (2091)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.Waiting for the device to be returned for evaluation.
Event or Problem Description
Catheter presented extravasation and limb edema.Catheter rupture.
Additional Manufacturer Narrative
The contract manufacturer reviewed the manufacture records for the lot reported.The returned device was manufactured and inspected according to specifications with no deviations, non-conformances, or authorized manufacture variances.An investigation of the returned device was conducted.Cross sections were cut to allow for relevant measurements of the device and found the dimensions were within specification.It was noted that the larger lumen was obstructed with blood clots.Based on the record review for the lot reported and the inspection of the returned device, it has been determined that the issue was not caused by the manufacturing process.A definitive root cause cannot be determined.

• Brand Name: 2.6F X 50CM DUAL LUMEN PICC
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8607377
• Report Number: 2518902-2019-00034
• Device Sequence Number: 16692616
• Product Code: LJS
• UDI-Device Identifier: 00884908085693
• UDI-Public: 884908085693
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2019

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/02/2021
• Device Model Number: MR17012601
• Device Catalogue Number: MR17012601
• Device Lot Number: MLJR720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 08/07/2019
• 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