Device evaluation summary: visual inspection shows one of the tubing connections is separated from the fitting.The device specification, bb9h75r7 shows the tubing is solvent bonded.The tubing was observed under magnification and there appears to be evidence of solvent residue.The tubing was installed onto the fitting.Pressure integrity testing was performed at 3 l/pm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.During the pressure integrity testing there was a leak observed from the tubing/fitting connection.Reason for return was confirmed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information that during use of a custom tubing pack, it was reported that the connector with luer in the arterial line was not secure and could easily come apart.The connector was too loose and the perfusionist stated that moving the loose connector around it allowed air to enter the arterial line.It was stated that the connector may be out of specification and a little too small or the tubing a little too big.It was also stated that the connector was too slippery, that maybe solvent had not been used and that maybe the connection should be bonded or tie banded.The device was used to complete the procedure.There was no patient impact associated with this event.Medtronic received additional information that there was no leak, air got into the circuit, but patient injury is not suspected.
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