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

Model Number	2230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent an unknown procedure on (b)(6) 2021 and a drain was used.During surgery when removing mediastinal chest tubes resistance noted.One of the 2 chest tubes was stuck and unable to be pulled out without a lot of force.Procedure stopped, chest tube clamped and removed with force.Upon removal distal end of chest tube was noted to be knotted.Patient experienced pain with removal.Patient given prescription pain medication.Patient remained stable throughout and was monitored closely post with no concerns.Type of incident/problem: during or after use.Level of harm: no apparent harm - reached patient/person, inconvenient.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information has been requested and received.Date of procedure? (b)(6) 2021.Date of event when product had an issue? (b)(6) 2021.During or after use? after use did the drain come in contact with sharp objects at any time: surgical instruments, surgical needles, sutures,? unsure.Did the drain function as intended? yes.Was drain removed after fulfilling need? yes.How was drain secured? sutured.Was the drain ¿knotted¿ upon placement? no.Please provide patient demographic information: id, age, gender, weight, bmi at the time of the index procedure? male, 18-64 years old, no other patient info available.What is the current status of the patient? no further adverse impact on patient.Additional information has been requested however not received to date.If further details are received at a later date a supplemental medwatch will be sent.Were there any anomalies with the drain: appearance, damage or function prior to use? where was the tip of drainage tube located? was the drain broken, as only a small piece of drain tubing was returned for analysis? if yes, describe when the drain broke? what is the physician¿s opinion as to the etiology of or contributing factors of this event? evaluation: product sample received.One used sample of drain was received for evaluation.During complaint evaluation, it was found that drain sample size received for evaluation is 70 mm instead of actual size 1200 mm.Sample was checked and no knot observed on the sample.Surface of the drain found smooth.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information received: the clinical user only sent the end of the tube that had the knot.She cut off the rest of the tube below the knot.The tube was not broken.Her concern is that the tube knotted at the end during the removal.The physician think the drain knotted in the patient, might not be an issue with the product per se.H3 evaluation: one used sample of drain was received for evaluation.During complaint evaluation, it was found that drain sample size received for evaluation is 70 mm instead of actual size 1200 mm.Sample was checked and no knot observed on the sample.Surface of the drain found smooth.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: 13638386
• Report Number: 2210968-2022-01414
• Device Sequence Number: 2174226
• Product Code: GBX
• UDI-Device Identifier: 10705031003583
• UDI-Public: 10705031003583
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

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: 2230
• Device Catalogue Number: 2230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 04/11/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male