Model Number 306546 |
Device Problem
Failure to Deliver (2338)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1019137, medical device expiration date: 2023-12-31, device manufacture date: 2021-02-16.Medical device lot #: 1035833, medical device expiration date: 2024-01-31, device manufacture date: 2021-06-03.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 the 10 ml bd posiflush¿ normal saline syringe experienced difficult plunger movement.The following information was provided by the initial reporter: the plunger would only flush up to approx the 3 or 4ml line and would not advance.I have saved the three syringes that this happened with.Not sure if perhaps the syringes got too hot in transit to our home this summer that might cause this or if something happened prior to shipment.We used the flush initially not knowing there was a problem until it suddenly would not advance past the 3 or 4ml mark.
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Manufacturer Narrative
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The following fields were updated due to corrected information: d.4.Medical device lot #: unknown.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.6.Investigation: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Dhr could not be performed due to unknown lot#.The complaint could not be confirmed and the root cause is undetermined.H3 other text : see h.10.
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Event Description
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It was reported that the 10 ml bd posiflush¿ normal saline syringe experienced difficult plunger movement.The following information was provided by the initial reporter: the plunger would only flush up to approx the 3 or 4ml line and would not advance.I have saved the three syringes that this happened with.Not sure if perhaps the syringes got too hot in transit to our home this summer that might cause this or if something happened prior to shipment.We used the flush initially not knowing there was a problem until it suddenly would not advance past the 3 or 4ml mark.
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Search Alerts/Recalls
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