MAUDE Adverse Event Report: PR006 PUERTO RICO-ANASCO 7FR SILICONE DRAIN W/TROCAR; CATHETER, IRRIGATION

Model Number	SU130-0320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer sample was not available for evaluation.It is vital to the investigation that the customer sample be available for examination and testing.The device history record (dhr) for the finished good and sub-assemblies was reviewed and no incident was documented that could cause this type of nonconformance.Based on the limited information provided a root cause for the reported concern could not be determined.As a preventive action, the customer will be provided with a copy of the instructions for use.It is recommended to strictly follow the instructions provided in the instruction for use (ifu) data included with the product to ensure drains are properly used.
Event or Problem Description
The customer reports product failure after surgery is completed, stating the product broke off inside the patient, requiring a second surgery for removal.

• Brand Name: 7FR SILICONE DRAIN W/TROCAR
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer (Section G): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 18032986
• Report Number: 1423537-2023-01000
• Device Sequence Number: 15503653
• Product Code: GBX
• UDI-Device Identifier: 10192253022223
• UDI-Public: 10192253022223
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2023

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 Model Number: SU130-0320
• Device Catalogue Number: SU130-0320
• Device Lot Number: 1211492
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown