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

Model Number	MD17012600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the picc broke at the distal end of the hub.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.
Additional Manufacturer Narrative
An investigation has been initiated.Currently waiting for additional information and notification if the device will 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.
Additional Manufacturer Narrative
The piccs were secured to the patients using a device called a securacath which is manufactured by interrad medical, inc.The catheters were initially sent to a securacath representative for a review.Once their investigation was completed the piccs were sent to medcomp (without the securacath devices that were used with the piccs).An unused sample was provided.Medcomp engineering department was asked to review the piccs.The first sample was pinched.The lumen collapsed which should have resulted in poor flow.It appears that there is a stress point where the lumen exits the securacath, and that any movement would put stress on the same point until potentially breaking.This in addition to being pinched probably resulted in the break due to fatigue.A picture pulled from the internet showed how the distance between the hub and securacath align with where the break was on the 2.6f picc.The second sample was not pinched but looks like it did bend long enough to fatigue and break where it exits the backside of the securacath.The lumen has an irregular break and cracks.In addition, it appears the lumen exiting the hub is elongated as if it was pulled on.The lumen was reduced in size (diameter) in all axes.It is impossible to determine with certainty that the securacath itself caused the failures.It could have been a result of active patients, poorly secured catheters, or a combination of them all.It is believed that the catheter failed for reasons other than design or manufacturing.

• 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: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 14242544
• Report Number: 2518902-2022-00031
• Device Sequence Number: 17365150
• Product Code: LJS
• UDI-Device Identifier: 00884908146509
• UDI-Public: 884908146509
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2022

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: 01/16/2025
• Device Model Number: MD17012600
• Device Catalogue Number: MD17012600
• Device Lot Number: MQAV360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/28/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SECUACATH BY INERRAD MEDICAL INC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 YR
• Patient Sex: Female