Catalog Number 394600 |
Device Problem
Break (1069)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/22/2022 |
Event Type
malfunction
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Event Description
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It was reported that the bd® quincke spinal needles experienced a broken needle.The following information was provided by the initial reporter: gets stuck and has been breaking in the patient's vein.
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Manufacturer Narrative
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Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Manufacturer Narrative
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H6: investigation summary no photos or physical samples that display the reported condition were available for investigation.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.As the lot involved in this incident is unknown, a device history review cannot be performed, and additional retained samples cannot be evaluated.Based on the available information we are not able to identify a root cause at this time.
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Event Description
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It was reported that the bd® quincke spinal needles experienced a broken needle.The following information was provided by the initial reporter: gets stuck and has been breaking in the patient's vein.
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Manufacturer Narrative
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The following fields were updated due to additional information: d4: medical device lot #: 0006976; d4: medical device expiration date: 31-dec-2022; h4: device manufacture date: 31-jan-2020.H6: investigation summary as no sample was returned, a thorough sample investigation could not be completed.Damages like these on the stopcock housing do not occur in our production process.The appearance of these cracks is typical for cracks that can occur when the product has been used together with lubrication solution or infusion with high ph-value.These solutions can release internal stress in the product.If excessive force is used when connecting and using the product for more than 24 hours, this may cause the material to crack.We recommend referring to the instructions for use, which is enclosed in each box.A device history record review was completed for provided material number 394600, lot 0006976.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.H3 other text : see h10.
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Event Description
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It was reported that the bd® quincke spinal needles experienced a broken needle.The following information was provided by the initial reporter: gets stuck and has been breaking in the patient's vein.
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Search Alerts/Recalls
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