Catalog Number UNKNOWN |
Device Problem
Separation Problem (4043)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.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 franklin lakes fda registration number has been used for the manufacture report number.
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Event Description
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It was reported when using the an unknown bd product devices are sticking to the apparatus and some do not re-sheath.The following information was provided by the initial reporter.The customer stated: "it was reported by the customer that transfer devices are sticking to the apparatus and some do not re sheath.".
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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.H3 other text : see h.10.
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Event Description
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It was reported when using the an unknown bd product devices are sticking to the apparatus and some do not re-sheath.The following information was provided by the initial reporter.The customer stated: "it was reported by the customer that transfer devices are sticking to the apparatus and some do not re sheath.".
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Search Alerts/Recalls
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