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

Model Number	MD17012601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Bedside rn noticed leakage of blood tinged iv fluid around dressing.Picc team called and upon assessment noticed leaking at insertion site when flushed with ns.Removed picc and upon examination, noticed a ruptured area that was under the insertion site.
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.
Additional Manufacturer Narrative
The vascu picc was returned for evaluation.Visual inspection revealed two distinct kinks in the lumen, one at 7 cm from the hub and the other at 10 cm from the hub.Dried blood was removed from the distal end of the catheter.It cannot be determined if this was in place at the time of event or if it may have contributed to the event.Flushing the device through the luer with the red clamp no leaks were noted.However, when flushing through the luer with the white clamp a leak was noted at the 10 cm mark, where the device is kinked.Under magnification it is seen that the kink at 7 cm has rippled and bubbled, while the lumen has burst at the 10 cm kink.It can be seen that the burst was from the inside out.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 manufacture 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.The device was in use for more than one month prior to the event with no reported issues.We are unable to determine the circumstances that may have led to this event.The instructions for use (ifu) contains the following warnings and precautions: do not use infusion equipment which can exceed the working pressure of 1.0bar max/750mmhg (14.5 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 small syringes will generate excessive pressure and may damage the catheter.The use of 10cc or larger syringes are recommended.Do not use sharp instruments near the extension lines or catheter lumen.Warning: do not flush against resistance.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: 14957693
• Report Number: 2518902-2022-00043
• Device Sequence Number: 12499010
• Product Code: LJS
• UDI-Device Identifier: 00884908146493
• UDI-Public: 884908146493
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K102966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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: 11/01/2023
• Device Model Number: MD17012601
• Device Catalogue Number: MD17012601
• Device Lot Number: MQDZ810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• 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: 06/22/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2022
• 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: 7 YR
• Patient Sex: Female