MAUDE Adverse Event Report: ETHICON INC. BLAKE 7MM FLAT FULL; CATHETER AND TIP SUCTION

Model Number	2211
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The following information was requested, with no response to date: was the drain being pulled and broken while removal after completion of its use? did the drain piece remain in the patient's body after it was broken? was the drain piece removed? if yes, was the patient taken back to hospital/operating room to remove the broken piece? or was it removed at the same time in the clinic? how? how is patient's condition? lot number of the blake drain used is complaint for a jackson pratt drain (non-ethicon product) or blake drain (ethicon)? attempts to obtain the additional information have been made.To date the information and device has not been received.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported a patient underwent an unknown procedure and a drain was used.A drain was pulled from a patient in the clinic and when pulled the drain was split.The manufacturer is not clear.There was no adverse consequence for the patient reported.The device is not available for return.Additional information requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to fda: 8/25/2020 corrected information: d2, d2b, d3, g1, g2, g5.

• Brand Name: BLAKE 7MM FLAT FULL
• Common Device Name: CATHETER AND TIP SUCTION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8492149
• Report Number: 2210968-2019-80100
• Device Sequence Number: 14342274
• Product Code: JOL
• UDI-Device Identifier: 10705031003477
• UDI-Public: 10705031003477
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K953655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2019

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: 2211
• Device Catalogue Number: 2211
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 08/25/2020
• Patient Sequence Number: 1