Model Number 385100 |
Device Problems
Break (1069); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/12/2022 |
Event Type
malfunction
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Event Description
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It was reported that 5 bd q-syte luer access split septums were damaged, but still operable and leaked.The following information was provided by the initial reporter: "on (b)(6), 2022, qsyte found during the infusion of patients: there were 5 of trachoma in the diaphragm shell of the joint for a period of time in the department, resulting in fluid leakage".
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1210001.Medical device expiration date: 2026-06-30.Device manufacture date: 2021-08-09.Medical device lot #: 1210002.Medical device expiration date: 2026-06-30.Device manufacture date: 2021-08-05.
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Manufacturer Narrative
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H6: investigation summary: our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed a q-syte with no product documentation to indicate the reference or lot number.A syringe is seen attached to the female port of the q-syte.Two beads of liquid can be seen forming on the q-syte near the vent hole and at the weld line.As no damage is seen to the q-syte near the weld line it is likely that the bead of fluid seen at that location likely originated from the vent hole and flowed down the outside of the body.Leakage at the vent hole could happen if there is a tear in the q-syte septum column wall or bottom disk.The reported issue was confirmed.Although the reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.Also, as the device has been opened and used, it cannot be determined with certainty whether the defects originated during manufacturing or use of the device.A device history record review showed no non-conformances associated with this issue during the production of this batch.
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Event Description
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It was reported that 5 bd q-syte luer access split septums were damaged, but still operable and leaked.The following information was provided by the initial reporter: "on (b)(6) 2022, qsyte found during the infusion of patients: there were 5 of trachoma in the diaphragm shell of the joint for a period of time in the department, resulting in fluid leakage.".
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Search Alerts/Recalls
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