Catalog Number 394910 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2023 |
Event Type
malfunction
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Event Description
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It was reported that bd connecta plus1 360 white blend had cracks the following information was provided by the initial reporter; it was reported by the customer that there were cracks in the stopcocks.Verbatim: we have received product with cracks in the stopcocks.
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Manufacturer Narrative
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H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Manufacturer Narrative
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Our quality engineer inspected the 3 photos and 1 physical sample submitted for evaluation.The reported issue of crack with leak was not confirmed upon inspection of the samples.Analysis of the sample and photos showed that it is not a bd product and therefore no further investigation could be performed.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the sample.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.
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Event Description
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Material #: 394910 , batch #: 2276782.It was reported by the customer that there were cracks in the stopcocks.Verbatim: we have received product with cracks in the stopcocks response received on 08-nov-2023: 1.Are you able to provide the quantity of defective stopcocks involved? yes, sent 1 back today.2.Please confirm if there was any patient involvement? yes.3.Was this noted before use or during use? it was actively in use on a patient.Response received on 16-nov-2023: 1.Could you please confirm if there was any adverse event or serious injury involved? none.2.What was the patient outcome? n/a.3.What type of procedure was being performed? none.Stopcock started leaking independently.4.Was the procedure completed as planned? how was it resolved? n/a.
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Search Alerts/Recalls
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