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Model Number SB-110-HU1007 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device history record was reviewed and confirmed the device lot was manufactured to specification.The scope buddy plus tubing instructions for use state, "warnings & precautions inspect tubing for leaks and damage to the plastic fittings.Do not use tubing if any damage is noted." users are instructed to wear proper ppe during use of the scope buddy in the user manual.The scope buddy endoscope flushing aid user manual states, "operator safety avoid biological contamination and chemical burns.Always wear appropriate personal protective equipment (ppe) including clothing, gloves, and safety glasses when handling used endoscopes." medivators will evaluate returned product from the customer.A follow-up mdr will be submitted when additional information becomes available.
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Event Description
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The user facility reported that their scope buddy plus tubing was sliding off during flushing of endoscopes and the sink water is being sprayed onto employees.No report of injury.
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Manufacturer Narrative
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The customer returned five samples of the tubing to medivators for evaluation.The returned tubing was not labelled, so the lot number of the tubing could not be determined.The packaging for tubing was included with the returned product which was labelled for lot number 532949 and 528534 (lot number subject of this mdr).The tubing is for 24-hour use only.The returned product was tested and three out of the five samples popped off; however, it is unknown how long this tubing had been in use at the user facility.Five samples of current inventory for lot number 536365 at medivators was tested and no issues were noted; the tubing did not pop off.The device history record was reviewed and confirmed the device lot number 528534 was manufactured to specification.The scope buddy plus tubing instructions for use state, "warnings & precautions inspect tubing for leaks and damage to the plastic fittings.Do not use tubing if any damage is noted." users are instructed to wear proper ppe during use of the scope buddy in the user manual.The scope buddy endoscope flushing aid user manual states, "operator safety 2.Avoid biological contamination and chemical burns.Always wear appropriate personal protective equipment (ppe) including clothing, gloves, and safety glasses when handling used endoscopes." no additional issues have been reported.
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Search Alerts/Recalls
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