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

Model Number	MD170126024S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The involved device was not returned for evaluation.One photograph was provided showing a split in the lumen approximately 5 cm in length.The exact location of the split cannot be determined from the photograph.Requests for additional information, including the length of time the device was implanted, were not successful.The contract manufacturer conducted a review of the manufacture records for the lot number provided.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.Without an evaluation of the device a root cause cannot be determined.Flushing against resistance is a common cause for lumen breakage.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.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.
Event or Problem Description
An end user reported an issue with a vascu-picc tls pediatric 2.6fx50cm dl mst kit, that was placed into a patient in the neonatal intensive care unit (nicu).Three days after picc placement, the nicu noticed a right femoral extravasation of 61%.When ir arrived to remove the line and place a new one, a longitudinal split along the catheter was noted.The device related failure was reported to have led to patient harm.

• 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: 15078887
• Report Number: 2518902-2022-00044
• Device Sequence Number: 11756793
• 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 Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: MD170126024S
• Device Catalogue Number: MD170126024S
• Device Lot Number: MQDB120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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: 8 WK
• Patient Sex: Male