Initial reporter phone#: (b)(6).Medical device lot #: unknown.Medical 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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Investigation summary: dhr review could not be performed due to unknown batch #.Sample evaluation: 1 loose 1ml ll syringe was received and reported to be from unknown batch.The sample was visually evaluated.The syringe had damaged/cracked luer collar with pieces of the collar loose in the bag.The remaining collar had visible cracks in it.The device that was being attached to the syringe was not provided.It is unknown from the sample, what was the reason for the collar failure.Due to the sample having been manipulated prior to arrival and the lack of additional supporting information, product defect could not be confirmed to be attributed to the manufacturing process.Photo evaluation: two photos were received by bd canaan and evaluated.A single 1ml ll assembled syringe is depicted in the photos.The luer collar is cracked and shattered in several places with at least one piece on the table next to the syringe.According to the description the failure occurred during attempted connection to another device.It is unknown what device the product was being attached to and how the connection was being handled.There is insufficient information to determine the root cause of the failure at this time.Based on the information available, the failure could not be attributed to the manufacturing process of the syringe.Investigation conclusion: ¿ unconfirmed: bd canaan was not able to duplicate or confirm the customer's indicated failure.
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