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Catalog Number 2241B |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/29/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint#: (b)(4).Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.What is the lot number? j1920858.Did the drain come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time? no further information is available.How was the case completed? no further information is available.What is the current condition of the patient?=>no further information is available.Device return status: the device has been received at sukagawa and will be shipped.Please check rmao.No further information will be provided." qty to be returned : 1, 2.Qty of product involved : 1, 2.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Note: events reported on mw#: 2210968-2022-08478.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.
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Event Description
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It was reported a patient underwent a spinal surgery on (b)(6) 2022 and a drain was used.During surgery, through normal way of using, the trocar was inserted and it was tried to be taken out from the epidermis, but the connection part between the product and the tube was broken immediately.The product was used on subcutaneous.Further details are not provided.There were no adverse consequences to the patient.Additional information has been requested.
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Manufacturer Narrative
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Product complaint # (b)(4) additional information: d9.H3 evaluation: two complaint samples were received for evaluation.During visual inspection, partial part of drain is found adhered to embedded area of the trocar, which shows that bonding between needle and drain is strong visible impression marks are also found on the needle side of the trocar, which indicate that some external factors like improper handling or improper usage at user end could not be ruled out.Further investigation of the sample was not possible.Retain samples were checked for lot# and no defect related to complaint was observed.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.
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Search Alerts/Recalls
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