Catalog Number 326631 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date : unknown.Initial reporter phone# : (b)(6).Initial reporter zip code : (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Medical device manufacture date : unknown.
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Event Description
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It was reported that 1 bd syringe 0.3ml 29ga 1/2in hub separated from the device.The following information was provided by the initial reporter : the customer reported that the shield was tighter than usual to remove and when pulling it hard the needle with the shield was separated from the barrel.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-14.H6: investigation summary.Customer returned (1) loose 3/10cc, 12.7mm syringe.Customer states that the shield was tighter than usual to remove , and when pulling it hard, the needle with the shield was separated from the barrel.The returned syringe was tested to determine the shield removal force (specs: shield removal force for 3/10cc after sterilization: 0.85-5.95 lbs.).The shield removal force was measured as 4.81 lbs., which fall within specifications.Also, the hub assembly did not separate from the barrel when the shield was removed.Unable to perform dhr check due to an unknown lot number for does not detach as intended (needle shield).Bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.
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Event Description
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It was reported that 1 bd syringe 0.3ml 29ga 1/2in hub separated from the device.The following information was provided by the initial reporter : the customer reported that the shield was tighter than usual to remove and when pulling it hard the needle with the shield was separated from the barrel.
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Search Alerts/Recalls
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