H.6 investigation summary: material 296266 is manufactured by rehydrating the media components with usp purified water, and thoroughly mixing until a homogeneous solution is obtained.The tubes are filled, capped, torqued, and then labeled by machine per standard operating procedure (sop).The tubes are terminally autoclaved in an air over pressure (aop) autoclave, per manufacturing instructions, using a validated cycle.Post autoclaving, tubes are packaged into final shipping configurations.The batch history record review for batch 2005284 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, torqueing, and packaging processes were within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other cap defect complaints have been taken on this batch for broken tubes.Retention samples from batch 2005284 (10 tubes) were available for inspection.There was no evidence of broken tubes observed in 10/10 retention samples.Two photos were received to assist with the investigation: ¿ the first photo shows a partial tube from batch 2005284.The tube is inside of a plastic bag the tube does appear to be cracked and leaking inside of the bag.¿ the second photo shows a tube from batch 2005284, inside of a plastic bag.The tube does appear to be broken.No returns were received to assist with the investigation.This complaint can be confirmed from the evidence provided by the photos.No actions are indicated at this time as no trends were observed.Bd will continue to trend complaints for broken tubes.Bd ships product in temperature controlled trucks to distribution centers.Distribution centers are provided with shipping and storage guidelines.Mishandling of the product and vibrations during shipping can cause broken tubes.H3 other text : see h.10.
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