MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 7F X 60CM DUAL PRO-LINE CT

Model Number	MRCTC72001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Extravasation (1842); Swelling/ Edema (4577)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated.Currently waiting for additional information and the device to 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.
Event or Problem Description
Patient with new r neck tissue ischemia above hickman with concern for pressor extravasation.Patient has r ij hickman and permacath placed by ir on thurs (redacted date).Over weekend and into beginning of following week patient noted to have large swings in pressor requirements.He also stated having brady arrythmias.On tues (redacted date) patient note to have mod amt of drainage coming from old r ij quinton site above the hickman.On the morning of (redacted date) upon exam patient noted to have increased edema and new tissue necrosis.Ct soft tissue neck and chest obtained.R neck soft tissue noted to have subcutaneous gas.Hickman did appear in correct place.Egs consulted, concerned for pressor extravasation to r neck which probably has been happening ovcer time as seeing late signs of extravasation.Hickman also visualized through hole of old quinton site.New femoral ij tlc placed and when pressors changed to tlc requirements significantly decreased.Ir consulted and hickman and permacath removed at bedside and brought to (redacted name) office.
Additional Manufacturer Narrative
The medwatch received contained insufficient information for an investigation on medcomp?s part.Requests for additional information, clarification of the incident, and device return were not successful.No device was returned for evaluation and no photographs were provided.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 manufacturing 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 the requested clarification, additional information, or an evaluation of the device a root cause cannot be determined.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: 7F X 60CM DUAL PRO-LINE CT
• Common Device Name: PRO-LINE
• 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: 19249284
• Report Number: 2518902-2024-00036
• Device Sequence Number: 20665795
• Product Code: LJS
• UDI-Device Identifier: 00884908097177
• UDI-Public: 00884908097177
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K093309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/09/2024

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 Model Number: MRCTC72001
• Device Catalogue Number: MRCTC72001
• Device Lot Number: MRBT420
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male