The reported issue was confirmed.It was concluded that the following was the root cause: supplier ¿ root cause.Inadequate verification and validation activities of the crimping process.Single pull test did not provide stability of process.Evidence was not provided when requested for maintenance of records or crimp tools.No crimp cross-sections provided.The dhr review is not required.A labeling review is not required because labeling could not have prevented this issue.H11: section a through f - the information provided by bd represents all 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.H3 other text : the actual/suspected device was inspected.
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It was reported that they performed visual and inspection and determined that the ac cca card and power module has degraded due to electrical overstress and will be replaced preventatively.The l-tube and double l-tubing appeared distended and expanded , however water flow was not impeded, it would be replaced preventatively as part of the preventive maintenance.
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