Catalog Number 309620 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.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 bd¿ catheter tip syringe plunger was difficult to move while aspirating and pushing out fluid.The following information was provided by the initial reporter: "syringe is difficult to use, it does not glide smoothly and is very tight when aspirating and pushing fluids occurrences: 1 each.No adverse event reported".
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Manufacturer Narrative
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H.6.Investigation summary: a device history record review was completed by our quality engineer team for provided material number 309620 and lot number 2210378.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
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Event Description
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It was reported that the bd¿ catheter tip syringe plunger was difficult to move while aspirating and pushing out fluid.The following information was provided by the initial reporter: "syringe is difficult to use, it does not glide smoothly and is very tight when aspirating and pushing fluids occurrences: 1 each.No adverse event reported.".
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Search Alerts/Recalls
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