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Catalog Number RF048F |
Device Problems
Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The lot number for the five reported malfunctions were not provided, therefore lot history reviews were not performed.For another two malfunction the lot number was provided and lot history review was performed.The devices were not returned, however, medical records were provided for six out of seven malfunctions.For four of the malfunctions that provided medical records perforation of the ivc were confirmed.For two malfunction that provided medical records the investigation is identified for perforation of the ivc.For the remaining 1 malfunction, medical records were not provided for review, therefore the investigations is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based upon the available information, the definitive root cause is unknown.The devices are labeled for single use.
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Event Description
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This report summarizes seven malfunctions.A review of the reported information indicated that model rf048f vena cava filter was allegedly experienced perforation.This information was received from various sources.All seven malfunctions were involved with no patient consequences.Three of the patients were male and three were female.Three male patient's ages ranged from 33-63 years and three female patient age ranged from 50-75.One patient age and weight not provided.All other patients weight not provided.
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Manufacturer Narrative
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H10: of the seven reported malfunctions, one was reassessed for reportability and determined to be reportable as a serious injury and was reported under emdr 2020394-2022-90010.The lot number was provided for two out of six malfunctions; therefore, a lot history reviews were performed.The devices were not returned for evaluation.However, medical records were provided and reviewed for five malfunctions and for the remaining one malfunction, medical record was not provided.Five malfunctions were confirmed for the reported perforation.The remaining one malfunction is inconclusive for the alleged perforation.Based upon the available information, the definitive root cause is unknown.The devices were labeled for single use.H10: g3,d4(corporate lot no).H11: b5.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 six malfunctions.A review of the reported information indicated that model rf048f vena cava filter allegedly experienced perforation.This information was received from various sources.All six malfunctions were involved patients with no reported consequences.Two of the patients were male and three were female.Two male patient's ages ranged from 33-56 years and three female patient's ages ranged from 50-75 years.One patient age and gender was not provided.All the reported six patients weight were not provided.
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Search Alerts/Recalls
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