MAUDE Adverse Event Report: BEILUN PLASTECH INC PMI; PMI OPERATIVE CHOLANGIOGRAPHY CATHETER FOR TRADITIONAL OPEN PROCEDURE

Model Number	PMIORCB
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a lap chole, [the surgeon] inserted a cholangiogram catheter (pmiorcb) through a small incision in the abdomen.[the surgeon] is a general surgeon with multiple years of experience with the procedure and with pmiorcb.During insertion of the catheter, the tip/bend of the product broke off.This portion of the catheter remained in the patient's subcutaneous tissue in the right upper quadrant of the abdomen.The broken portion was located using x-ray imaging and removed.[the surgeon] was able to enlarge the incision and completely remove the catheter tip that had broken off.The patient's clinical outcome was reportedly "good." the surgery time was extended, but the patient experienced no complications post-op.

• Brand Name: PMI
• Common Device Name: PMI OPERATIVE CHOLANGIOGRAPHY CATHETER FOR TRADITIONAL OPEN PROCEDURE
• Manufacturer (Section D): BEILUN PLASTECH INC; no. 18 moju rd; daqi industry zone; ningbo, cn 31580 6; CH 315806
• MDR Report Key: 22666723
• Report Number: 3009495876-2025-00001
• Device Sequence Number: 7767645
• Product Code: GBZ
• UDI-Device Identifier: 00812608021017
• UDI-Public: 00812608021017
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/30/2025
• Report Date (Section F): 07/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2026
• Device Model Number: PMIORCB
• Device Catalogue Number: PMIORCB
• Device Lot Number: 010230801
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/09/2025
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2025
• 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: Unknown