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

Model Number	MR17012601
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated.Currently waiting for the return of the device for evaluation.
Event or Problem Description
"on friday night, (b)(6) 2018, the cicu requested a double lumen picc line placement for a patient.The line was placed and the patient was sent back to their room with a moderate but acceptable amount of post procedure bleeding.On monday, (b)(6) 2018, the cicu contacted ir reporting that the bleeding had worsened after using tpa in the line and that an excessive amount of blood had been lost.It was also reported that whenever maintenance fluids were given, leaking around the access site would occurred.From the description of the problem ir concluded that the line might be defective.The patient was brought back down to ir where the line was replaced.Upon evaluating the line which had been removed, a hole within 1 cm of the hub was noticeable.The line was saved, labeled, and packaged to send to clinical engineering.".
Additional Manufacturer Narrative
The 2.6f picc was returned for investigation and forwarded to the contract manufacturer for evaluation.The contract manufacturer conducted a record review of the reported lots.All lots were manufactured to specifications with no anomalies or non-conformances.A review of the returned device revealed the burst lumen was visible to the naked eye.The lumen was further reviewed and found to have no blockages and all dimensions were within specifications.The root cause of the burst lumen 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: 8004528
• Report Number: 2518902-2018-00055
• Device Sequence Number: 1301408
• Product Code: LJS
• UDI-Device Identifier: 00884908085693
• UDI-Public: 884908085693
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K102966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2019

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: 12/12/2020
• Device Model Number: MR17012601
• Device Catalogue Number: MR17012601
• Device Lot Number: MLAP660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 06/25/2019
• 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