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	10/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Attempts have been made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The reported device 'rectus sheath catheter' is not an ethicon blake drain product code 2231.They are 2 different products.If the product is actually an ethicon blake drain product code 2231, please provide the following information- procedure name, location where the broken drain is retained in patient, size of the retained broken piece, surgeon's opinion about drain piece left in the patient? is the patient suffering adverse consequences? if yes, what medical/ surgical intervention is provided to manage the patient's consequences? any there any plans in place to remove the broken piece from the patient? lot number of the drain? to date the device has not been received.If further details or the device 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 on (b)(6) 2018 and a drain was used.Multiple attempts to remove rectus sheath catheter (post surgery two days prior) however this resulted in the catheter breaking leading to a foreign body being left in patient's lower abdomen.Additional information requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Sent to the fda: 05/14/2019.Additional information: hospital has informed that she doesn¿t have any further information.It was the patient that made the complaint, it wasn¿t about the product.Based on this information, we are unable to confirm if ethicon device was involved in the incident.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/8/2020.Correction: d2, d2b, g1, g2, g5.

• Brand Name: BLAKE (R) DRAIN 19FR R/F
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8519916
• Report Number: 2210968-2019-80409
• Device Sequence Number: 3118536
• Product Code: GBX
• UDI-Device Identifier: 10705031003590
• UDI-Public: 10705031003590
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: CL I EXEMPT
• 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,Followup
• Report Date (Section B): 03/18/2019

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: 2231
• Device Catalogue Number: 2231
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 04/16/2019; 08/17/2020
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/14/2019; 09/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention