It was reported that the temperature displayed was not good on the day of using the extension cord for temperature sensing foley catheter.It was stated that the date of use was unknown.Per follow up information received via ibc on oct 05, 2022.It was stated that the reported event was no temperature display.Per notification received from investigator on mar 01, 2023.It was reported that the during evaluation, the dimensions of the cable plug were found to be out of specifications.
|
It was reported that the temperature displayed was not good on the day of using the extension cord for temperature sensing foley catheter.It was stated that the date of use was unknown.Per follow up information received via ibc on 05oct2022, it was stated that the reported event was no temperature display.Per notification received from investigator on 01mar2023, it was reported that the during evaluation, the dimensions of the cable plug were found to be out of specifications.
|
The reported event is confirmed, supplier manufacturing related.Photo samples were submitted.However, could not be evaluated for the reported failure.The extension cable was returned without the original packaging.No damage to the cord was noted.Connections of the cord to the plug and socket were secure.Using a multimeter, the cord was tested for and found to have continuity.The cord was connected to an in-house temperature sensing catheter submerged in a water bath set to 37c, the cord was then attached to a kilo device and the temperature displayed erratically from no reading, and ranged from 32.6 c to 36.9c.Though the temperature displayed erratically, the sample meets the specification "plug and jack must be firmly secured to wire.".Using a caliper the cable was measured and found to be above specifications for the middle of indention to mono jack, plastic insulator to mono jack, tip diameter, and indention diameter measurements.As the cable is supplied by wonik corporation u.S.A., ltd.(f.K.A international importers) this event will be confirmed supplier related.A potential root cause for this event could be operator error.The lot number is unknown; therefore, the device history record could not be reviewed.A label/pack review is not required as a review of the label could not have prevented the reported event.H11: section a through f - the information provided by bd represents all 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.H3 other text : the actual/suspected device was evaluated.
|