10.
H.
6.
Eval codes: method: other: visual examination and mechanical torque testing of retentions performed and device history records reviewed by contract mfr, remel inc.
Raw material inspection records reviewed, dimensional and polariscope analysis performed by glass vendor.
H.
6 eval codes: results: customer/returned product: one tube was found to have two elongated cracks.
Retention samples: mechanical torque testing: average off-torque was within acceptable range.
Dimensional analysis: all measurements were within specs.
Polariscope analysis confirmed that tubes were properly annealed.
Visual examination, device history record review and raw material inspection review were acceptable.
H.
6 eval codes: conclusions: shipping/handling contributed to the event.
Investigation revealed defective tubes may be the result of improper stacking and/or handling by freight carrier during shipping process.
Interim corrective action implemented by contract mfr to label pallots "do not double stack.
" investigation of shipping/handling rigors is ongoing by dade microscan inc.
Eval summary: remel inc.
, the contract mfr of this product, performed the following eval of the product; review of device history record and associated documents, review of mfg equipment and processes, review of incoming inspection records, visual and off-torque analysis of retention samples.
Review of the original raw material quality records, dimensional, and polariscope analysis were performed by the glass vendor.
There have been no changes in the mfg processes, equipment and packaging of the product deemed as contributory to the event.
Eval of the retention samples and review of quality assurance documentation indicates the tubes met required specs.
In january of 1999, the shipping carrier was changed to a frieght carrier (other than remel inc.
) to comply with routing guidelines provided by the spec developer, dade microscan inc.
Defective tubes may be the result of improper stacking and/or handling during the shipping process.
The addition of placards to each pallet of product stating "do not double stack" has been implemented to address this concern.
Investigation of shipping/handling rigors is ongoing by dade microscan inc.
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