MAUDE Adverse Event Report: BEILUN PLASTECH INC PMI; PMI COMBO PACK - CHOLANGIOGRAM CATHER WITH DISPOSABLE PERCUTANEOUS INTRODUCER

Model Number	PMIORCAP20
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On october 12th a laparoscopic cholangiogram catheter with part number pmiorcap20 and lot number 030220401 was tagged as defective after the tip disconnected from the catheter as the surgeon was inserting it in the patients gallbladder for dye infusion for a cholangiogram.It was not reported that the tip was ever loose inside the patient.No harm to patient or complications were reported.No adverse event was reported.The device in question was not returned for investigation.This is the first product problem with pmiorcap20 lot number 030220401.Only one device from the lot of 200 is affected.There have been no similar reports for this lot or this device as a whole.Patient information not available.

• Brand Name: PMI
• Common Device Name: PMI COMBO PACK - CHOLANGIOGRAM CATHER WITH DISPOSABLE PERCUTANEOUS INTRODUCER
• Manufacturer (Section D): BEILUN PLASTECH INC; no. 18 moju rd; daqi industry zone; ningbo, cn 31580 6; CH 315806
• MDR Report Key: 18196256
• Report Number: 3009495876-2023-00001
• Device Sequence Number: 20471505
• Product Code: NWT
• UDI-Device Identifier: 00812608021529
• UDI-Public: 00812608021529
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/22/2023
• Report Date (Section F): 11/22/2023

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: 04/21/2024
• Device Model Number: PMIORCAP20
• Device Catalogue Number: PMIORCAP20
• Device Lot Number: 030220401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2023
• Device Age: 19 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown