MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN 19FR R/F; WOUND DRAINAGE SYSTEM

Model Number	2230
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.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 surgery on an unknown date and a drain was used.Before opening the package, it was found that there had been a foreign substance like a hair in the package.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/20/2020.H3 evaluation: we received one 2230 drain in unopened osp.There is a piece of hair looking like eyelash inside the secondary pouch.There is eyelash inside the pouch.The complaint is confirmed.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

• Brand Name: BLAKE (R) DRAIN 19FR R/F
• Common Device Name: WOUND DRAINAGE SYSTEM
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9956595
• Report Number: 2210968-2020-02998
• Device Sequence Number: 2808143
• Product Code: KOG
• UDI-Device Identifier: 10705031003583
• UDI-Public: 10705031003583
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K953655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

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 Expiration Date: 03/19/2024
• Device Model Number: 2230
• Device Catalogue Number: 2230
• Device Lot Number: J1906614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2019
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 05/20/2020
• Patient Sequence Number: 1