Catalog Number UNKNOWN |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 02/09/2023 |
Event Type
Injury
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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 franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.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 when using the unspecified urine collection device there was a needle stick injury - post use.The following information was provided by the initial reporter.The customer stated: there was a "needle stick injury with urine transfer device.".
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.
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Event Description
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It was reported when using the unspecified urine collection device there was a needle stick injury - post use.The following information was provided by the initial reporter.The customer stated: there was a "needle stick injury with urine transfer device.".
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Search Alerts/Recalls
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