Catalog Number 309570 |
Device Problems
Break (1069); Leak/Splash (1354); Loose or Intermittent Connection (1371)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/30/2019 |
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.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that an unspecified number of syringe 3ml ll w/ndl 25x5/8 rb experienced a needle that broke/detached, and a loose needle which was noted during use.The following information was provided by the initial reporter: material no: 309570 batch no: unknown.309570 - it was reported the needle is disconnecting from the syringe at the base, either snapping off and seems to be loose.Caller states this has occured with about 5 or 6 units.Lot number(s)/serial number(s) were not available at this time for either catalog number as the caller needed to retrieve this information from the staff.The date of incidents for both catalog numbers are not known.
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Manufacturer Narrative
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H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.H3 other text : see h.10.
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Event Description
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It was reported that an unspecified number of syringe 3ml ll w/ndl 25x5/8 rb experienced a needle that broke/detached, and a loose needle which was noted during use.The following information was provided by the initial reporter: material no: 309570, batch no: unknown.309570: it was reported the needle is disconnecting from the syringe at the base, either snapping off and seems to be loose.Caller states this has occured with about 5 or 6 units.Lot number(s)/serial number(s) were not available at this time for either catalog number as the caller needed to retrieve this information from the staff.The date of incidents for both catalog numbers are not known.
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Search Alerts/Recalls
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