MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS; 5FR 2L PICC LINE TRAY

Catalog Number	PICC0020
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025 when removing the picc line that was placed on (b)(6) 2025 because "the catheter tip migrated into the azygous vein and became hard to flush and unable to aspirate a blood return" the catheter was "very coiled" upon removal.The customer reported a new picc was placed in a "different vein proximal to the original site" due to the reported incident.The customer reported there was "no serious injury identified", and the patient has had "no further issues".The customer did not report any serious injury related to the reported incident.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, on (b)(6) 2025 when removing the picc line that was placed on (b)(6) 2025 because "the catheter tip migrated into the azygous vein and became hard to flush and unable to aspirate a blood return" the catheter was "very coiled" upon removal.

• Common Device Name: 5FR 2L PICC LINE TRAY
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; tri-state de mexico; s. de r.l. de c.v; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22506961
• Report Number: 3004519921-2025-00028
• Device Sequence Number: 15769215
• Product Code: LRO
• UDI-Device Identifier: 10653160364733
• UDI-Public: 10653160364733
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 06/16/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Catalogue Number: PICC0020
• Device Lot Number: 2023122290
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/29/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 73 KG