MAUDE Adverse Event Report: ETHICON, INC. BLAKE DRAIN; CATHETER, IRRIGATION

Model Number	2214
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The neurosurgeon was at bedside to remove a bulb suction drain (blake drain) from a one-day post-surgical patient.The patient had a l5-s1 transforaminal lumbar interbody fusion and right l4-5 laminotomy/foraminotomy with intraprocedural drain placement on (b)(6) 2024 and was being prepared for discharge.Upon removing the sutures of the drain and gently pulling on the device, the drain "came apart, leaving a portion of the drain inside the patient" near the point of entry.The neurosurgeon attempted to remove the drain fragment from the patient but was unsuccessful.The patient requires return to the operating room for surgical removal of medical device.The patient had not been npo and therefore was required to stay in the hospital for an additional day to safely complete intervention.

• Brand Name: BLAKE DRAIN
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON, INC.
• MDR Report Key: 19877196
• Report Number: MW5157860
• Device Sequence Number: 7778390
• Product Code: GBX
• UDI-Device Identifier: 10705031003507
• UDI-Public: (01)10705031003507
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/26/2024

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 Model Number: 2214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic