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

Model Number 2232

Device Problem Leak/Splash (1354)

Patient Problem Hypoxia (1918)

Event Date 01/21/2022

Event Type  Injury  

Event Description

It was reported a patient underwent an unknown cardiovascular surgery on (b)(6) 2022 and a drain was used.Left thoracic and mediastinal drains were inserted.After surgery, the drain was broken.On (b)(6), at 2 o'clock, two nurses performed a position change.Immediately after the change, a sound of air leakage could be heard.The area where the sound was coming from was checked, and it was found that the chest drain was damaged.The thoracic drain was clamped, and the damaged part was fixed with a elastikon, then it was reported to the attending physician.The physician instructed to leave the chest drain clamped.There was no difference in lung sounds between the right and left sides, and there was no subcutaneous emphysema, but the patient's spo2 was decreased, so it was coped with increasing oxygen.(b)(6), an x-ray was taken, and the attending physician confirmed that the patient did not have a pneumothorax.The patient did not touch the route.Further details are not provided additional information has been requested.

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 alleged deficiency with the drain? two nurses performed a position change.Immediately after the change, a sound of air leakage could be heard.The area where the sound was coming from was checked, and it was found that the chest drain was damaged.Were there any anomalies with the drain: appearance, damage or function prior to use? no further information is available.During or after use? it was found during use.Did the drain come in contact with sharp objects at any time: surgical instruments, surgical needles, sutures? no further information is available.Did the drain function as intended? no further information is available.Was drain removed after fulfilling need? no further information is available.Where was the tip of drainage tube located? left thoracic and mediastinal.How was drain secured? no further information is available.Please provide patient demographic information: id, age, gender, weight, bmi at the time of the index procedure? no further information is available.What is the current status of the patient? no further information is available.Lot number of drain? no further information is available.What is the physician¿s opinion as to the etiology of or contributing factors of this event? no further information is available.It was noted there were "no adverse patient consequences", however they were mentioned in event.Please clarify.No further information is available.How much was the patient's spo2 decreased? no further information is available.How much was oxygen increased? no further information is available.No further information will be provided.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: d9.H3 evaluation: product sample received.According to the information received, after an unknown cardiovascular surgery, the drain was broken.During complaint evaluation it was found that one used sample received for evaluation with small drain piece covered on it.As per the complaint statement, ".Two nurses performed a position change.Immediately after the change, a sound of air leakage could be heard.The area where the sound was coming from was checked, and it was found that the chest drain was damaged." there could be mishandling of product when the patient position was changed.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
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): DEGANIA SILICON LTD.-INDIA; 251, sector-6, imt manesar; gurgaon ; IN
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13578553
• MDR Text Key: 285946949
• Report Number: 2210968-2022-01229
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003606
• UDI-Public: 10705031003606
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

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
• Device Operator: Health Professional
• Device Model Number: 2232
• Device Catalogue Number: 2232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/22/2022
• Supplement Dates Manufacturer Received: 03/14/2022
• Supplement Dates FDA Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention