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Model Number 8881106010 |
Device Problems
Difficult to Advance (2920); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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An investigation is currently underway.Upon completion, the results will be forwarded.
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Event Description
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Customer reports: the plunger doesn¿t move and cannot draw volume into syringe.On 07sep2022 the sales rep provided additional information stating the customer confirmed that it is was the plunger that is broken, not the pump.The customer further stated that they package the syringes into a custom kit and then sterilize them which means they are unable to trace back to the exact material lot since all of the occurrences were from a kit.There was no reported patient impacts.Based on the additional information received there are several potential affected lots.Lot numbers: 203978x, 131271x, 203978x, 201825x ,203977x, 131276x, 201826x, 100457x, 131270x, 128444x, 201826x, 128443x are all potential lot numbers.The true affected lot number(s) is not known.
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Manufacturer Narrative
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A device history record for the reported potential lots confirmed that the product was produced accomplishing quality requirements and released according to established procedures.Product and specification requirements were met with no non-conforming product identified relating to this customer report.The manufacturing site received twenty-three syringe assemblies in an unsealed 6cc syringe kit identified with hct3916-1 lot 221245035 exp.Date 2024-05-04.A complete investigation was performed.Visual inspection to the quality inspection standard was conducted however there were no issues identified.Subsequently, a leak testing was conducted to verify that the syringe draws, holds, and expels fluid properly by inserting the syringe into a rubber block for resistance.All twenty-three syringe assemblies passed the leak testing.The reported condition of the plunger not moving or unable to draw volume into the syringe cannot be confirmed.Possible causes for the syringe to not draw insulin as designed could be that the cannula is partially plugged or occluded.A plugged or occluded cannula may occur if the insulin crystallized, if there is uneven distribution of silicone, or improper technique.Occluded cannula detectors are installed on the assembly machines and are checked each shift to ensure that they are working properly.If the silicone is unevenly distributed, exercising the plunger would redistribute the silicone in the barrel and on the rubber tip.These syringes are designed to be a single use syringe.Possible causes of tight plunger action could include uneven silicone on the rubber tip or the barrel, plugged/occluded cannula, insulin crystallization, or improper technique.Exercising the plunger in the barrels prior to use will redistribute the silicone and make the plunger action easier.Complaint trends are evaluated during a monthly corrective/preventative action (capa) meetings to determine if a capa is warranted.At this time, there is not enough information and a capa will not be initiated.However, the reported condition will be communicated to the appropriate quality and manufacturing personnel to heighten awareness.
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Search Alerts/Recalls
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