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

Model Number	MD170126024S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	04/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.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
Placed the picc a few days prior to the reported event.Call from the picu with the concern that the line was leaking.The patient's arm was swollen and the picc was not aspirating.The picc was assessed it, and experienced air upon aspiration from the hubs.The line was removed by the nurse and noted to have significant compromise.
Additional Manufacturer Narrative
The complained device was received after the complaint was originally closed, as it was shipped to the distributor instead of to medcomp as instructed.The complaint was re-opened for further investigation.Visual inspection confirmed the complaint as the lumen has a tear just below the hub.The tear is approximately 1 cm in length with the edges flaring out.The device subassembly is received from an external supplier and is visually and functionally inspected.Incoming inspection includes visual inspection for kinks, holes, gaps, and functional testing for leaks.At the completion of the final manufacture processes, the catheters are 100% leak tested.Catheter lumens with damage, such as holes, ruptures, tears and/or small pinholes will be detected during this test.A definitive root cause cannot be determined.Excessive external pressure applied to the lumen may be a contributing cause for this type of failure.The instructions for use (ifu) contains the following warnings, precautions, and statements: small syringes will generate excessive pressure and may damage the catheter.The use of 10cc or larger syringes are recommended.Do not flush against resistance.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.
Additional Manufacturer Narrative
No device was returned for evaluation and no photographs were provided.The lot number was not provided.Multiple requests for additional information and device return were unsuccessful.Without the lot number a review of the manufacture records is not possible.Without an evaluation of the device a root cause cannot be determined.No investigation is possible.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
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 16833032
• Report Number: 2518902-2023-00035
• Device Sequence Number: 20616088
• Product Code: LJS
• UDI-Device Identifier: 00884908147230
• UDI-Public: 00884908147230
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K120981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2023

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 Model Number: MD170126024S
• Device Catalogue Number: MD170126024S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 04/25/2023; 04/25/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 06/05/2023; 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown