MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN 19FR R/F; CATHETER, IRRIGATION

Model Number	2230
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information has been requested and obtained.Attempts to obtain the device however not received.If further details are received at a later date a supplemental medwatch will be sent.What is the lot number? no further information is available.Did the drain come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time? no further information is available.If broken post op when removing drain from the patient: the drain was broken from the beginning.Was the broken drain removed completely from the patient? please see above.Were any pieces left inside the patient? please see above.If yes, was the patient taken back to the operating room to remove the broken drain surgically? if not already removed, are there any plans in place to remove the drain from the patient? what is the current condition of the patient? no further information is available.Device return status: the device has been received at sukagawa and will be shipped.Please check rmao.No further information will be provided.
Event or Problem Description
It was reported a patient underwent an unknown procedure on (b)(6)2022 and a drain was used.The drain was broken from the beginning.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4) additional information: d9 h3 evaluation: one used sample of damaged drain was received for evaluation, size 85 mm (actual size of drain is 1200 ± 15 mm).During evaluation of complaint, drain sample found with slit cut which seems to be done with sharp object.Complete drain sample not received for evaluation.Manufacturer performing 100% visual inspection before release of product.So this defect can not be generated during manufacturing process.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: BLAKE (R) DRAIN 19FR R/F
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): DEGANIA INDIA; 251, sector-6, imt manesar; gurugram ; IN
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13860513
• Report Number: 2210968-2022-02018
• Device Sequence Number: 5295988
• Product Code: GBX
• UDI-Device Identifier: 10705031003583
• UDI-Public: 10705031003583
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: CL I EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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 Model Number: 2230
• Device Catalogue Number: 2230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown