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Model Number 2227 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Additional information has been requested and received.Please provide product code for jvac reservoir? no further information is available.2179.Please provide lot number jvac reservoir => reservoir lot number is ju0540 please provide lot number for blake drain =>no further information is available.2227/unk.Is the reservoir available for return? no further information is available.Status of product return? the device has been received at sukagawa and will be shipped.Please check rmao.No further information will be provided.Additional information has been requested however not received.Attempts have been made to obtain the device, however not received to date.If further details are received at a later date a supplemental medwatch will be sent.Please clarify: is the complaint for 1 or 2 drains and 1 or 2 reservoirs? note: events reported on mw# 2210968-2022-05054, mw# 2210968-2022-05055.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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Event Description
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It was reported a patient underwent a spinal fusion on (b)(6) 2022 and a drain was used.The reservoir was completely swollen when these were removed in the ward.The cause was considered to be air leak, but there was also a possibility that the drain insertion site was displaced.Further details are not provided.There were no adverse consequences to the patient.
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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.Please clarify: is the complaint for 1 or 2 drains and 1 or 2 reservoirs? 1 drain and 1 reservoir.No further information will be provided.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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Manufacturer Narrative
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Product complaint # (b)(4).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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Manufacturer Narrative
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Product complaint # (b)(4).Additional information: d9, h6 component code: g07002 product not confirmed.H3 evaluation: product sample received for analysis.During investigation of complaint, one used sample of drain received for evaluation.One used sample of drain tied with suture near dot marking area was received for evaluation.During inspection of sample, no hole or tear found on the drain sample.Lot number of sample unknown.Reservoir not received for evaluation.Retain sample analysis could not be performed as the lot no.Is unknown.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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