MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO ONE-STEP; CATHETER, IRRIGATION

Model Number	00884450012062
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during the drainage of an abcess, the centesis catheter broke and part of the catheter remained in the patient.The 3.5 cm of catheter that remained in the patient required removal in the or two days later.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: ONE-STEP
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• MDR Report Key: 12052617
• Report Number: 3011642792-2021-00007
• Device Sequence Number: 11729972
• Product Code: GBX
• UDI-Device Identifier: 00884450012062
• UDI-Public: 00884450012062
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: 02/11/2024
• Device Model Number: 00884450012062
• Device Catalogue Number: OSC-5F-10L/B
• Device Lot Number: I2043290
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1