Model Number JADA 1001 |
Device Problems
Component Incompatible (1108); Component or Accessory Incompatibility (2897); Compatibility Problem (2960)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/08/2022 |
Event Type
malfunction
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Event Description
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This spontaneous report was received from a physician via a health care professional and a company representative, referring to a female patient of unknown age.This report concerns 1 device and 1 patient.The patient's past medical history, concurrent conditions and concomitant medications were not reported.On (b)(6) 2022, a complaint was received regarding vacuum-induced hemorrhage control system (jada system).It stated that on (b)(6) 2022, "luer lock separated from end of catheter when inflating; needed to be held on with tape" (device issue).The device lot number was reported on the device complaint as 1070802 (expiration date not reported).It was currently unknown if the device was retained.A follow up request to the site was made regarding device retention and additional details of this case.It was reported that the event caused hospitalization and an intervention was required.Medical device reporting criteria: malfunction (b)(4).No health consequences or impact (no apparent harm occurred in relation to the adverse event).
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Manufacturer Narrative
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This report represents a potential malfunction.The device is assembled according to specifications.In process and finished product testing are performed and approved prior to release.The investigation is currently ongoing; a follow up report will be submitted upon completion of the investigation.
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Event Description
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This spontaneous report was received from a physician via a healthcare professional and a company representative, referring to a female patient of unknown age.This report concerns 1 device and 1 patient.The patient's past medical history, concurrent conditions and concomitant medications were not reported.On 12-apr-2022, a complaint was received regarding vacuum-induced hemorrhage control system (jada system).It stated that on (b)(6) 2022, "luer lock separated from end of catheter when inflating; needed to be held on with tape" (device issue).The device lot number was reported on the device complaint as (b)(4) (expiration date not reported).It was currently unknown if the device was retained.A follow up request to the site was made regarding device retention and additional details of this case.The event of device issue was determined to be medically significant.This is the final report.Executive summary: medical device reporting (mdr) had been reported for this event.A complaint sample was not provided by the complainant.The lot number reported for the vacuum-induced hemorrhage control system (jada system) 1 device was 1070802.No aberrations to the process were noted during device history record review by the device manufacturer.A potential failure of the luer-lock valve can be produced if the luer lock syringe is twisted into the inflation valve instead of inserted directly.To disassemble the resulting stuck syringe requires it to be forcefully removed, bringing the inflation valve with it.To reduce the likelihood of this failure mode occurring, a design change for vacuum-induced hemorrhage control system (jada system) 2 occurred which changed the luer connection configuration and dimensions which aim to create stronger assembly connections.Medical device reporting criteria: malfunction fda code (health effects - health impact code annex f): 2199 no health consequences or impact (no apparent harm occurred in relation to the adverse event.).
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Manufacturer Narrative
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Mdr has been reported for this event.A complaint sample was not provided by the complainant.The lot number reported for the jada 1 device is 1070802.No aberrations to the process were noted during device history record review by the device manufacturer.A potential failure of the luer-lock valve can be produced if the luer lock syringe is twisted into the inflation valve instead of inserted directly.To disassemble the resulting stuck syringe requires it to be forcefully removed, bringing the inflation valve with it.To reduce the likelihood of this failure mode occurring, a design change for jada 2 occurred which changed the luer connection configuration and dimensions which aim to create stronger assembly connections.
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Search Alerts/Recalls
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