MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN 10FR ROUND; CATHETER, IRRIGATION

Model Number 2227

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Additional information was requested and the following information was obtained.To date product not received.If further details are received at a later date a supplemental medwatch will be sent.Did the patient require revision surgery? no.If yes, please specify? n/a.Did the patient require hardware removal? no.If yes, what hardware product was removed? n/a.Please specify what intervention was performed? the part of the drain that had a hole, was cut away, but there was still enough of the drain left, so they used it on the patient.The part with the hole was not in the patient body, but outside of the patient body.The customer noticed the hole in the drain, because the suction was not working and the bleeding occurred with the patient.When they cut the part with the hole on the drain, the bleeding was stopped.What device was explanted? the drain? no.How was the bleeding managed? explained above.The event describes this as occurring post op, on what post op day did the event happen? immediately after the procedure, when the patient was already in the normal patient room.Procedure date? (b)(6) 2020.Procedure name? spine decompression.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported a patient underwent a spine decompression procedure on (b)(6) 2020 and a drain was used.After the drain was inserted into the patient, bleeding occurred on same day as surgery.There was no suction from the drain, a hole was noted in the drain.The part of the drain that had a hole, was cut away.There was still enough of the drain left and continued use on the patient.The part with the hole was not inside the patient body, but outside of the patient body.When they cut the part with the hole on the drain, the bleeding/leak was stopped.No additional drain was used on the patient.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to fda: 3/3/2021.Additional information: h6 component code: g07002 device not returned.H3 evaluation: complaint sample was not received from the customer for evaluation.However, complaint sample photograph was received for analysis but on the basis of photograph it can not be corelate the leakage due to manufacturing process.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Complaint information is trended on a regular basis to determine if further investigation is warranted.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.

Manufacturer Narrative

Product complaint # (b)(4) date sent to the fda: 5/11/2021 additional information: d6a, d6b, d9, h4 corrected data: d3 the device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.H3 evaluation: complaint sample was received from the customer for evaluation.After opening the complaint sample primary pack, it was observed that there was a small piece of drain.The complaint sample (drain) was not in original its length.The actual length of drain is 1200mm however, the size of complaint drain was 300mm.The complaint sample photograph was received for analysis but on the basis of photograph it can not be corelated the leakage due to manufacturing process.Retain sample of the same lot were checked visually and found within the specified criteria.There was no hole, damage or crack on the drain.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.Product complaint # (b)(4) date sent to the fda: 5/11/2021 corrected data: d3 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 10FR ROUND
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11273298
• MDR Text Key: 230083952
• Report Number: 2210968-2021-01032
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003552
• UDI-Public: 10705031003552
• Combination Product (y/n): N
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2021

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
• Device Operator: Health Professional
• Device Model Number: 2227
• Device Catalogue Number: 2227
• Device Lot Number: J1923327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 02/15/2021; 04/14/2021
• Supplement Dates FDA Received: 03/03/2021; 05/11/2021
• Patient Sequence Number: 1