The lot number was provided and a lot history review was performed.The sample was not returned for evaluation; however, a photo was provided for review.The catalog number identified has not been cleared in the us, but is similar to the universal drainage catheters with nitinol products that are cleared in the us.The pro code for the universal drainage catheters with nitinol products is identified.The investigation is still underway.The device was labeled for single use.
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H10: the lot number was provided and a lot history review was performed.The catalog number identified in section d4 has not been cleared in the us, but is similar to the universal drainage catheters with nitinol products that are cleared in the us.The pro code for the universal drainage catheters with nitinol products is identified in d2.The sample was not returned for evaluation; however, a photo was provided for review.The investigation is inconclusive for the alleged issue.Based on the available information definitive root cause could not be determined.The device was labeled for single use.H10: g4.H11: g1, h6, (method, results & conclusion) 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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