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	Insufficient Information (4580)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
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
Line was leaking iv fluid and blood.Per the rn, the patient was alive after the line was removed and received another line.However, there was a clabsi so she cannot be certain that having a line that was compromised had no contribution.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation and no photographs provided.The exact location of the leak is unknown.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 holes, leaks, or weak areas if they had existed at the time of manufacture.Without an evaluation of the device a root cause cannot be determined.The catheter was implanted for 48 days prior to the leak.The report indicated the patient had this line removed and received another line.In addition, it was reported the patient had a central line associated blood stream infection (clabsi).There is no indication the clabsi was associated with the patient?s death.Infection and thrombosis are the two most common complications of central line catheters, and both are noted in the instructions for use (ifu).The instructions for use (ifu) contains the following warnings and precautions that should be followed to minimize the occurrence of holes, tears, and leaks in the catheter.Do not use infusion equipment which can exceed the working pressure of 1.0 bar max/750mmhg (14.5 psi).Only use infusion equipment complying with standards, which do not exceed a shut-off pressure of 1.0 bar.Bolus injections should be slow and must not exceed the maximum bolus pressure of 1.2 bar/900mmhg (17.4 psi).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.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: 12954832
• Report Number: 2518902-2021-00069
• Device Sequence Number: 11969559
• Product Code: LJS
• UDI-Device Identifier: 00884908146493
• UDI-Public: 884908146493
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: 09/01/2022
• Device Model Number: MD17012601
• Device Catalogue Number: MD17012601
• Device Lot Number: MPQF690 S2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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: Death; Required Intervention
• Patient Age: 31 WK
• Patient Sex: Male
• Patient Weight: 1 KG