Catalog Number NNU8LPT |
Device Problem
Crack (1135)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Of the four reported malfunctions, two lot numbers were provided and a lot history review will be performed.For one malfunction, the investigation of the reported event is inconclusive as the sample was not returned and no images or medical records were provided.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.One malfunction provided an electronic photo, another provided a video.The company is still investigating this issue.
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Event Description
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This report summarizes four malfunction.The information reviewed indicated that model nnu8lpt drainage catheter allegedly experienced a crack.This information was received from various sources.All four of the reported malfunctions involved patients with no reported consequences.One (b)(6) year old patient's weight and gender were not provided.Age, weight, and gender were not provided for the other patients.
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Manufacturer Narrative
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H10: of the four reported malfunctions, two lot numbers were provided and a lot history review will be performed.For one malfunction, the investigation of the reported event is inconclusive as the sample was not returned and no images or medical records were provided.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.One malfunction provided an electronic photo, another provided a video.The company is still investigating this issue.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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This report summarizes four malfunctions.The information reviewed indicated that model nnu8lpt drainage catheter allegedly experienced a crack.This information was received from various sources.All four of the reported malfunctions involved patients with no reported consequences.One 70 year old patient's weight and gender were not provided.Another patient was male.Age, weight, and gender were not provided for the other patients.
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Manufacturer Narrative
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H10: out of the four reported malfunctions, two lot numbers were provided and a lot history review was performed.The samples were not returned to the manufacturer for inspection/evaluation; however for two malfunctions a photo and a video has been provided and reviewed.For the one of the malfunctions, break and leak was confirmed.For the other malfunction, crack was confirmed.The remaining 2 malfunctions are inconclusive as no objective evidence was provided for review.Based upon the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.H10: g4 h11: g1, h6(result, conclusion) h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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This report summarizes four malfunctions.The information reviewed indicated that model nnu8lpt drainage catheter allegedly experienced a crack.This information was received from various sources.All four of the reported malfunctions involved patients with no reported consequences.One 70 year old patient's weight and gender were not provided.Another patient was male.Age, weight, and gender were not provided for the other patients.
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Search Alerts/Recalls
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