There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received. the lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.
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It was reported while using an unspecified bd intima ii catheter the end cap was loose and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2022, the heparin cap on the bd20 intravenous indwelling needle fell off during the process of returning the patient to the ward after the left upper lung wedge resection in our hospital, resulting in blood leakage, and the bed sheet was contaminated.
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