Catalog Number UNKNOWN |
Device Problem
Volume Accuracy Problem (1675)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: 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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Event Description
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It was reported that the scale markings on the unspecified bd¿ insulin syringe were incorrectly graduated.The following information was provided by the initial reporter, translated from spanish to english: "i have a complaint about the graduation of your brand's syringes, i preferred them since they are the best to administer and manipulate insulin, but a few days ago i noticed a lack of glucose control in my patient and today when i administered his dose i realize that the syringe is wrongly graduated.The first line comes to the edge in some syringes, in others it is well located, in others lower.I imagine that if you have any idea that the doses must be exact and thanks to their poor quality can generate a health problem for whoever is using them.".
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Manufacturer Narrative
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Investigation: customer returned an image of two syringes.The scale markings are present but not immediately flush with the uppermost tip of the body of the syringe.The markings do not appear to be significantly off-center.These markings would require proper measurement to ensure that they fell within specifications.However, since they were not returned for investigation, the samples cannot be measured.Due to the batch being unknown, no dhr review can be completed.Based on the image received, bd was unable to confirm the customer¿s indicated failure of glucose levels issues since the samples could not be measured directly to ensure they are within specifications.H3 other text.
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Event Description
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It was reported that the scale markings on the unspecified bd¿ insulin syringe were incorrectly graduated.The following information was provided by the initial reporter, translated from spanish to english: "i have a complaint about the graduation of your brand's syringes, i preferred them since they are the best to administer and manipulate insulin, but a few days ago i noticed a lack of glucose control in my patient and today when i administered his dose i realize that the syringe is wrongly graduated.The first line comes to the edge in some syringes, in others it is well located, in others lower.I imagine that if you have any idea that the doses must be exact and thanks to their poor quality can generate a health problem for whoever is using them.".
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Search Alerts/Recalls
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