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

Model Number	MD17012601
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
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
Lue picc placed a month ago with multiple vascular access team (vat) consults due to no blood return on red lumen.Six doses of alteplase instilled over eight days, first few restored patency but today, after two unsuccessful doses of alteplase vat registered nurse (rn) reported that she placed l-cysteine in line even though no incompatible medications were infusing or have been infusing in the last several days.Assessment: requested x-ray of entire line path (last x-ray was done three days ago) and compared with previous images, the last image that showed that line was completely intact.The most recent two images showed an "unusual" "bulge" in line, near axillary region.Today, image shows a clear large tear in line near axilla.At bedside, assessed site under dressing and found drainage on the biopatch from the backflow / leakage.Resolution: always rule out a mechanical issue with line if occlusion issues continues despite alteplase tx.R/o mechanical issues by 1) taking down dressing to evaluate site 2) get a current x-ray of entire le path and compare images.No lcysteine needed if no incompatible medications infused.Ruptured picc line noted after removal due to repeated occlusion and x-ray imaging.Removed from patient, no harm to patient.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation and no photographs were provided.Requests for additional information were unsuccessful.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.The manufacturing process includes a 100% leak test performed as a last step in the process.This test would have detected any leaks, holes, or weak spots if it had existed at the time of manufacture.Without an evaluation of the device a root cause cannot be determined.The information provided in the incident report indicated there were multiple issues of patency/flow issues resulting in the use of "six doses of alteplase instilled over eight days".Excessive external pressure applied to the lumen by flushing against resistance may be a contributing factor for this type of failure.The instruction for use (ifu) includes common complications: catheter occlusion, damage/fracture of catheter, and thrombosis.Catheter maintenance section includes the following."a running infusion should be maintained at all times to ensure patency.A lock may be substituted for an infusion.The extension tube must not be clamped and then released after locking.This can cause blood to be aspirated back into the catheter lumen and result in a blocked catheter." the ifu also include the following warnings and precautions: * if resistance is encountered to aspirating or flushing, the lumen may be partially or completely occluded.Warning: do not flush against resistance.*small syringes will generate excessive pressure and may damage the catheter.The use of 10cc or larger syringes are recommended.* do not use infusion equipment which can exceed the working pressure of 1.0bar max/750mmhg (15.5 psi).* only use infusion equipment complying with standards, which do not exceed a shut-off pressure of 1.0bar.* bolus injections should be slow and must not exceed the maximum bolus pressure of 1.2bar/900mmhg (17.4 psi).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
• 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: 19351877
• Report Number: 2518902-2024-00040
• Device Sequence Number: 20690901
• Product Code: LJS
• UDI-Device Identifier: 00884908146493
• UDI-Public: 00884908146493
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2024

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?: No
• Operator of Device: Other
• Device Expiration Date: 02/01/2026
• Device Model Number: MD17012601
• Device Catalogue Number: MD17012601
• Device Lot Number: MQZP630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2023
• 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 Age: 5 MO
• Patient Sex: Female