Catalog Number UNKNOWN |
Device Problems
Disconnection (1171); Material Separation (1562); Device Dislodged or Dislocated (2923)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/25/2019 |
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.Device manufacture date: unknown.There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that stopper separation occurred with a unspecified bd syringe.The following information was provided by the initial reporter, "it was reported that the stopper separated from the plunger rod on one syringe and in another syringe the stopper was twisted and would not allow the plunger to move.Event description per customer's email states, "i have two 10ml syringes with luer lok tip that has dislodged/disconnected black piece from the plunger.One lost all suction and ability to be used and one the black piece is twisted and will not allow plunger to move.".
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Manufacturer Narrative
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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.A device history record review could not be performed as lot number was unknown.
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Event Description
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It was reported that stopper separation occurred with a unspecified bd syringe.The following information was provided by the initial reporter, "it was reported that the stopper separated from the plunger rod on one syringe and in another syringe the stopper was twisted and would not allow the plunger to move.Event description per customer's email states, "i have two 10ml syringes with luer lok tip that has dislodged/disconnected black piece from the plunger.One lost all suction and ability to be used and one the black piece is twisted and will not allow plunger to move.".
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Search Alerts/Recalls
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