Model Number CQF7584 |
Device Problems
Deflation Problem (1149); Material Frayed (1262); Retraction Problem (1536)
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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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For the reported malfunction, the device was returned to bd for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
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Event Description
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This report summarizes one (1) malfunction.A review of the reported information indicated that model cqf7584 pta balloon dilatation catheter allegedly experienced a deflation issue and failed to retract.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) year old male patient was (b)(6).
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Manufacturer Narrative
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The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation confirmed frayed material but could not confirm a deflation issue.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.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 one (1) malfunction.A review of the reported information indicated that model cqf7584 pta balloon dilatation catheter allegedly experienced a deflation issue and frayed material this information was received from one source.The malfunction involved a patient with no known impact to the patient.The 64 year old male patient was 173 lbs.
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Search Alerts/Recalls
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