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It was reported that when catheter peri care was performed, the foley catheter was noted to be defective, ribbed and removed along with a large blood clot.Then a new continuous bladder irrigation catheter was inserted with continuous bladder irrigation low-rate orders.Also stated that it looked like the catheter was heated up and the temperature coil became fused to one side of it.Also some of the coils were poking through and that was probably where some bleeding occurred.Per follow up on 02jun2021, the patient was started on continuous bladder irrigation.The temperature sensing coil was fused along the side of the catheter as the heat caused the two to became fused together and in some areas went through the catheter.The customer was not sure about how the temperature coil made it through the catheter and because of the coil shape it was described as ribbed.No medical intervention was reported.
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The reported event was confirmed however the cause was unknown.One sample were confirmed to exhibit the reported failure.The device had not met specifications.The product was used for patient treatment.The product caused the reported failure.Visual evaluation of the returned sample noted one unopened (with original packaging), lubri-sil temp sensing foley catheter.Visual inspection of the sample noted 1 three- way temp sensing foley catheter balloon and found that the wire was kinked on the return sample.This is considered a failure stating that " the wire should not be kinked, knotted or broken once is inserted in the lumen".A potential root cause for this failure mode could be" thermistor wires with a snake shape¿.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Sterile: unless package is opened or damaged.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Warning: this product should never be connected to the temperature monitor or connected to a cable during an mri procedure.Failure to follow this guideline may result in serious injury to the patient.Refer to the instructions for use.It is important to closely follow these specific conditions that have been determined to permit the examination to be conducted safely.Any deviation may result in a serious injury to the patient.Valve type: use luer slip syringe.Do not use needle.Recommended inflation capacities 8 fr.And 10 fr.(3cc balloon): use 3.5cc sterile water 12 fr.(5cc balloon): use 5.5cc sterile water 14 fr.And larger (5cc balloon): use 10cc sterile water do not exceed recommended capacities.Caution: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable laws and regulations.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.Note: compatible with appropriate 400-series temperature monitors.Interchangeability + 0.2oc at 37oc.Caution: as with all temperature probes: in the presence of rf energy sources: local heating, temperature errors, and probe damage may occur.In medical use, unplug the temperature-sensing catheter at the extension cable before activating electrosurgical or other types of direct coupled rf energy sources.Do not stretch catheter.This will cause repositioning of probe.Do not use stylet.This will cause stretching of catheter." corrections: d, g, h.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.H3 other text : the actual/suspected device was inspected.
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It was reported that when catheter peri care was performed, the foley catheter was noted to be defective, ribbed and removed along with a large blood clot.Then a new continuous bladder irrigation catheter was inserted with continuous bladder irrigation low-rate orders.Also stated that it looked like the catheter was heated up and the temperature coil became fused to one side of it.Also some of the coils were poking through and that was probably where some bleeding occurred.Per follow up on (b)(6) 2021, the patient was started on continuous bladder irrigation.The temperature sensing coil was fused along the side of the catheter as the heat caused the two to became fused together and in some areas went through the catheter.The customer was not sure about how the temperature coil made it through the catheter and because of the coil shape it was described as ribbed.No medical intervention was reported.Per follow up on (b)(6) 2021, the patient was started on continuous bladder irrigation.The temperature sensing coil was fused along the side of the catheter and in some areas went through the catheter.It was described as ribbed because of the coil shape.Customer was not sure how the temperature coil made it through the catheter.It was stated that the only way that makes sense was that at some point heat caused the two to become fused together.
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