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

Model Number	MR170126024S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Nursing noticed swelling, patient pain, discomfort when picc used.Patient brought to vir for picc exchange.Upon removal the device was noted to have cracked.
Additional Manufacturer Narrative
The device was returned for evaluation.A tear in the lumen is visible approximately 2 cm from the hub.This tear is consistent with the lumen bursting under pressure.Dried blood is visible inside the lumen just below the tear.If resistance was encountered when flushing the device or when injecting medications, the lumen could have undergone stresses it was not designed to withstand.A review of the manufacture records for the lot number reported revealed the lumen was manufactured according to specification with no non-conformances or abnormalities.As the device was implanted for 9 days prior to the occurrence, it is determined the root cause is most likely not manufacture related.A definitive root cause cannot be determined.The instructions for use (ifu) contains the following warnings and precautions: do not flush against resistance.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 of 1.2bar/900mmhg (17.4 psi).Small syringes will generate excessive pressure and may damage the catheter.The use of 10cc or larger syringes are recommended.Device was used for treatment, not diagnosis.

• Brand Name: 2.6F X 50CM DUAL LUMEN PICC W/MST
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10671448
• Report Number: 2518902-2020-00048
• Device Sequence Number: 2880884
• Product Code: LJS
• UDI-Device Identifier: 00884908147230
• UDI-Public: 884908147230
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K120981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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: 11/30/2022
• Device Model Number: MR170126024S
• Device Catalogue Number: MR170126024S
• Device Lot Number: MPCD780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 4