MAUDE Adverse Event Report: COVIDIEN DUAL LUMEN INSERTION TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	43311
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that there was a crack in the picc discovered upon hookup of new drips.The picc had lipids running at 1 ml/hr with no issue/leaking; however, when new drips hooked up at a total of 10.5 ml/hr combined, the picc was found to have a steady leak.
Additional Manufacturer Narrative
One used catheter which came inside of a plastic bag containing two clamps on both extensions and one posi flow which showed signs of use (blood) was received for analysis.The sample is from a 1.Fr dual lumen picc tray.During the leak test, the sample did leak confirming the reported issue.Manufacturing performs 100% leak testing as per procedure which would identify the reported issue during the catheter assembly process.This ensures components and finished products meet all quality inspection standards.These controls include but are not limited to material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.The uvc catheter showed signs of being used in a patient.For these reasons the potential cause may be attributed to the manner of which the device was used including any form of repositioning or movement of the product.It must be noted that in process controls such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: DUAL LUMEN INSERTION TRAY
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 9747194
• Report Number: 3009211636-2020-00688
• Device Sequence Number: 2511700
• Product Code: LJS
• UDI-Device Identifier: 20884527004680
• UDI-Public: 20884527004680
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: No Information
• Device Model Number: 43311
• Device Catalogue Number: 43311
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/15/2020
• Patient Sequence Number: 1