MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 2.6F X 50CM DUAL VASCU-PICC W/MST

Model Number	MD170126024S
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation is ongoing.A follow up report will be submitted when the investigation is complete.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
A leak was noted coming from the insertion site that would soak the dressing and linens surrounding the patient.The line was exchanged and after inspecting it, there is a pin hole leak that is distal to the hub that would be just inside the patient.It cannot be seen with the naked eye because it is too small but while flushing saline, there is a notable leak coming from there.On the cut internal portion, it was noted that there seemed to be a clot within the tube.Facility considered maybe it was more of a maintenance issue than a product issue at this point.
Additional Manufacturer Narrative
No device was returned and no photographs were provided.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation showed the device was manufactured according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test performed as the last step in the process.This leak test would have detected any holes, leaks, or weak spots in the catheter if it had existed at the time of manufacture.It was further reported that there appeared to be "a clot within the tube".Without an evaluation of the device the complaint cannot be confirmed and a root cause cannot be determined.The instructions for use (ifu) contains the following precautions and warnings: do not flush against resistance.Occluded/partially occluded catheter - if resistance is encountered to aspirating or flushing, the lumen may be partially or completely occluded.If the lumen will neither aspirate nor flush, and it has been determined that the catheter is occluded with blood, follow institutional declotting procedure.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.6F X 50CM DUAL VASCU-PICC W/MST
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 12385824
• Report Number: 2518902-2021-00052
• Device Sequence Number: 14352911
• Product Code: LJS
• UDI-Device Identifier: 00884908147230
• UDI-Public: 884908147230
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K120981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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: 05/25/2024
• Device Model Number: MD170126024S
• Device Catalogue Number: MD170126024S
• Device Lot Number: MPRD470
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 09/15/2021
• 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
• Patient Age: 4 MO