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

Model Number	2231
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested and was obtained.Date of bile duct procedure? (b)(6) 2021.Were there any anomalies with the drain: appearance, damage or function prior to placement? no.How was the drain secured? skin seam for fixation.Did the drain function as intended? yes.Were any issues noted with the drain during use? no.Were there any anomalies with the drain: appearance, damage or function while in use? no.What is the surgeons opinion of the impact of the drain on the patient consequences? re-op.Patients current status? no consequential damage.Additional information was requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Date of drain removal/event? lot number of drain? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported a patient underwent a hernia repair on (b)(6) 2021 and a drain was used.When the drain was removed, it broke and part of it remained in the abdomen.To remove the piece the patient was re-operated on.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/14/2021.Additional information: d9.H3 evaluation: complaint sample was received from the customer evaluation.After opening the pack drain sample was found in two pieces with black particles inside the drain as well inside the primary pouch.One piece of drain was 25mm and other piece was 100mm in length.However the complete length of original drain is 1200mm.The complete evaluation of the complaint sample could not be done.Evaluation of retain sample was not done as the lot number is not specified.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
• MDR Report Key: 11723973
• Report Number: 2210968-2021-03770
• Device Sequence Number: 3765261
• Product Code: GBX
• UDI-Device Identifier: 10705031003590
• UDI-Public: 10705031003590
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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: 2231
• Device Catalogue Number: 2231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2021
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 06/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention