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Catalog Number 309050 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/02/2023 |
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 discardit¿ ii syringe leaked.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from portuguese: "this complaint is to report the issue with the 5ml syringes.Stuck plunger, air entry."we have had several complaints from customers regarding bd brand 10ml and 20ml syringes.They complain of stuck plungers, air entry, and if they do not place the syringe in an upright position when positioning the syringe towards the collection tube there are several drips on the floor."".
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 07-aug-2023.H6: investigation summary a device history record review was completed for provided material number 309050 and lot number 2209184.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, one (1) picture sample and four (4) physical samples were returned for evaluation by our quality engineer team.The physical samples were reviewed; however, no signs of defect were observed.The provided physical samples did not display any functionality issues and the samples met all specifications and standards.On the other hand, the medication used by the customer or a special method of use (high temperatures, pressures, several uses, etc.) could affect the sliding properties of the syringes.Through inspection of the picture sample, leakage could be observed within the syringe.The leakage displayed in the picture could have resulted from damage in the plunger lip component.This type of damage may occur during the handling of the product through the manufacturing process or within the plunger assembly machine.
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Event Description
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It was reported that the bd discardit¿ ii syringe leaked.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from portuguese: "this complaint is to report the issue with the 5ml syringes.Stuck plunger, air entry."we have had several complaints from customers regarding bd brand 10ml and 20ml syringes.They complain of stuck plungers, air entry, and if they do not place the syringe in an upright position when positioning the syringe towards the collection tube there are several drips on the floor."".
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Search Alerts/Recalls
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