MAUDE Adverse Event Report: MC3 INC. CRESCENT JUGULAR DUAL LUMEN CATHETER 28FR

Model Number	70128
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Hematoma (1884); Swelling/ Edema (4577)
Date of Event	12/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has not yet been returned to manufacturer.From the information received, it appears that the catheter became stuck in the patient during insertion.It was pulled out with a force causing the catheter body to break near the catheter infusion port.
Event or Problem Description
Mc3 received information that a (b)(6) boy was being put on vv ecmo support when the catheter became stuck and broke off.The patient was transported to the operating room and it was determined that the broken piece of the catheter was firmly stuck behind the clavicle in the internal jugular vein.Attempts to extract the catheter revealed that it was entangled with the picc line.Patient was taken to interventional radiology and the decision was made to proceed with a sternotomy.The catheter tip was able to be removed and the patient was transferred back to pediatric intensive care.

• Brand Name: CRESCENT JUGULAR DUAL LUMEN CATHETER 28FR
• Common Device Name: DUAL LUMEN CATHETER 28FR
• Manufacturer (Section D): MC3 INC.; 2555 bishop circle west; dexter MI 48130
• Manufacturer (Section G): MC3 INC.; 2555 bishop circle west; dexter MI 48130
• Manufacturer Contact: martha rumford ; 2555 bishop circle west; dexter, MI 48130 ; 7349959089
• MDR Report Key: 13475132
• Report Number: 3011468686-2022-00001
• Device Sequence Number: 4826697
• Product Code: PZS
• UDI-Device Identifier: 10854916006802
• UDI-Public: 10854916006802
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K180151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2022

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: 70128
• Device Catalogue Number: 70128
• Device Lot Number: 2104156
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2022
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• 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: Required Intervention; Other
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Weight: 56 KG