Catalog Number 900116A |
Device Problems
Short Fill (1575); Defective Component (2292)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/13/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Event Description
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It was reported that there was an insufficient amount of water in the syringe.
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Event Description
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It was reported that there was an insufficient amount of water in the syringe.
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Manufacturer Narrative
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The reported issue was confirmed.The device was returned for evaluation.Visual inspection found there was plastic debris from the plunger stuck or trapped in between the gasket and inner wall of the barrel.It caused a void or channel and water leaked out.The sample has been sent to supplier.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿[contraindications] 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) this device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (5) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients (1) do not use in patients who are or have been allergic to natural rubber latex (2) patients with known allergy to silver coated catheter.".
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Event Description
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It was reported that there was an insufficient amount of water in the syringe.
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Manufacturer Narrative
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The reported issue was confirmed.The device was returned for evaluation.Visual inspection found there was plastic debris from the plunger stuck or trapped in between the gasket and inner wall of the barrel.It caused a void or channel and water leaked out.The sample has been sent to supplier.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿[contraindications] 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) this device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (5) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients (1) do not use in patients who are or have been allergic to natural rubber latex (2) patients with known allergy to silver coated catheter.".
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Search Alerts/Recalls
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