Catalog Number UNKNOWN |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/29/2021 |
Event Type
malfunction
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Event Description
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It was reported that the unspecified bd¿ pre-filled flush syringe leaked in the packaging.The following information was provided by the initial reporter, translated from chinese: "at 11:00 on (b)(6) 2021, when the nursing staff performed the indwelling needle vein sealing operation for the patient, they found that the unopened flush package was leaking, and then immediately replaced the flush to seal the patient tube operation".
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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.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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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.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that the unspecified bd¿ pre-filled flush syringe leaked in the packaging.The following information was provided by the initial reporter, translated from chinese: "at 11:00 on (b)(6) 2021, when the nursing staff performed the indwelling needle vein sealing operation for the patient, they found that the unopened flush package was leaking, and then immediately replaced the flush to seal the patient tube operation".
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Search Alerts/Recalls
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