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The reported event was confirmed, however the cause was unknown.Visual inspection noted that 4 photo samples and a video sample were received shown one used dignishield and one dignishield used for comparison.Visual evaluation noted the inflation port was disconnected and missing in the photos received.A video sample was received shown the failure on a demo catheter, that showed the inflation port easily disconnected from the catheter.This video correlates to the failure seen in the photos of the actual sample, where there was evidence that the inflation port was once connected, but was no longer attached.The reported event states that the cuff deflated, also given supporting evidence that the inflation port was once connected.The video and the photos also showed evidence of adhesive on the shaft where inflation port was connected demonstrating that the curing process for the inflation port did in fact occur.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure mode could be due to non appropriate material handling.The product used for the diagnostic purposes.The product did not meet the specifications, and was influenced by the reported failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "instructions for use: 1.Preparation of sms prior to insertion: a.Verify the retention cuff has been completely deflated.This can be done by squeezing the cuff to ensure there is no residual air inside the device.1) if air remains within the cuff, attach the 60 ml syringe to the green inflation port and withdraw all remaining air from the cuff.B.After the cuff has been fully deflated, fill the syringe with 45ml of water and set aside.C.Using a permanent marker, record the catheter insertion date on the label located on the piston valve connector.2.Collection bag connection.A.Attaching the collection bag: 1) attach the collection bag to the piston valve connector on the catheter by pulling back on the green trigger switch and engaging the piston valve connector onto the collection bag hub socket.2) ensure that the green ring at the base of the collection bag hub socket is not visible.The green ring at the base of the collection bag hub socket will not be visible when the piston valve is properly connected 3.Preparation of patient: a.The preferred patient position for catheter insertion is the left lateral knee-chest position, although the patient¿s clinical situation may dictate the use of an alternate position.The goal of patient positioning is to maximize sphincter relaxation to ease catheter insertion.B.Perform a digital rectal exam to evaluate for fecal impaction.If a fecal impaction is present, disimpaction procedure and device insertion may occur at the discretion of the healthcare professional.4.Insertion of device a.Unfold the length of the catheter to lay flat on the bed, extending the collection bag towards the foot of the bed.B.Attach the 60 ml syringe filled with 45 ml of water to the inflation port, but do not inflate.C.Insert the inflation cuff using a four-step process: 1) as previously stated in step 1, ¿preparation of sms prior to insertion¿, ensure the retention cuff is completely deflated.2) holding the left point of the cuff between the thumb and index finger, fold the top right point of the cuff down and to the left in a 45 degree angle, in order to create a conical shape with a leading edge for easy insertion.3) generously coat the patient¿s anus with lubricating jelly.4) gently insert the cuff end through the anal sphincter until the cuff is beyond the external orifice and well inside the rectal vault.D.Inflate the cuff with 45ml of water by slowly depressing the syringe plunger.The green inflation port has an external pilot balloon used as a guide to determine proper inflation; as the cuff inflates, the pilot balloon also inflates.The pilot balloon should be used as a reference to determine proper cuff inflation (figure 5).If the pilot balloon indicates over- or under-inflation, use the syringe to withdraw the fluid from the cuff, reposition the cuff in the rectal vault and reinflate.Ensure the inflation port remains parallel to the catheter in order to prevent kinking of the inflation lumen and blockage of injected fluid e.Remove the syringe from the green inflation port and gently pull on the drainage catheter to check that the cuff is securely in the rectum and that it is positioned against the rectal floor.F.Position the length of the flexible drainage tube along the patient¿s leg, avoiding kinks, obstruction and tension.Take note of the black position indicator line that is printed in the proximal segment of the tsz.Observe its relative position to the patient¿s anus.Observe changes in the location of the position indicator band as a means to determine movement of the retention cuff in the patient¿s rectum.This may indicate the need for the cuff or drainage tube to be repositioned.G.Hang the bag using the built-in hanger at a convenient location on the bedside (below the level of the patient¿s rectum).Irrigation of the retention cuff if the retention cuff area becomes obstructed with fecal matter, it may be irrigated by filling a syringe with tap water, attaching the syringe to the clear irrigation port and depressing the plunger (figure 7).Make sure the irrigation port remains parallel to the catheter in order to prevent kinking in the tubing and blockage of the injected water.Repeat the procedure as often as necessary to maintain proper functioning of the device.Ensure that water drains.6.Flushing of the drainage tube if the drainage tube becomes obstructed with fecal matter, flush the tube by filling a syringe with tap water, attaching the syringe to the purple ¿flush¿ port, and depressing the plunger.Make sure the flush port remains parallel to the catheter in order to prevent kinking in the tubing and blockage of the injected water.This is used to maintain an unobstructed flow of stool into the collection bag.If repeated flushing with water does not return the flow of stool through the catheter, the device should be inspected to determine if there is an external obstruction (i.E.Pressure from a body part or piece of equipment).If no source of obstruction of the device is detected, use of the device should be discontinued 7.Administration of medication a.Confirm the irrigation line is clear by attaching a luer lock syringe to the clear irrigation port (labeled ¿irrig¿) and flushing the system with water.B.Locate the tube clamp and place near the patient.(the tube clamp comes preattached to the piston valve hanger string.) c.Attach a luer lock syringe with the medication to be delivered (dosage as indicated and as prescribed by the treating physician) to the clear irrigation port (labeled ¿irrig¿).Elevate the drainage tubing to facilitate medication retention and infuse the prescribed amount of medication.To ensure delivery of medication into the rectum, immediately flush the irrigation line with at least 10ml of water (or volume per physician's orders).Note: some medication will reside between the clamp and the device opening.D.Slide the tube clamp onto the drainage tube until the drainage tube contacts the hinge.Position the tube clamp as close to the patient¿s buttocks as possible without touching the patient¿s skin.E.Using two hands to facilitate ease of closure, place thumb on thumb to snap the tube clamp shut.Ensure the patient does not lie on the tube clamp.If the clamp is difficult to close or excessive leakage of medication is observed, reposition the tube clamp on the drainage tube.F.Dispose of the syringe according to institutional policy.G.After the prescribed dwell time, remove the tube clamp and reattach to the piston valve hanger string.Verify unobstructed flow from the patient into the collection bag.8.Stool sampling.A.Uncap the white sample port.B.Gently kink the catheter segment between the piston valve connector and the sample port.C.Tilt or milk the catheter to collect fecal matter around the sample port.D.Insert a slip-tip syringe into the sample port valve and draw the appropriate sample of fecal matter into the syringe.Withdraw the syringe.E.Secure the white cap back onto the sample port.9.Removal/replacement of the collection bag to remove the collection bag, grab the piston valve connector, gently pull backward on the switch located on the slide of the connector until the piston ejects from the collection bag hub.The piston valve and bag hub should close off automatically in this process.Once the bag is removed, insert the bag cap into the hub connector and dispose of the collection bag in accordance with institutional protocol for disposal of medical waste.Replace the collection bag by securely snapping a new bag to the connector (reference step 2).Collection bag reorder # is sms2b1le.A.Collection bag removal / replacement: 1) remove the collection bag by pulling back on the green slide and the piston valve until it disengages from the collection bag hub socket.2) insert the bag cap onto the bag hub socket and dispose of the bag in accordance with hospital policy and protocols.3) collection bag reorder number: sms2b1le.10.Removal of device.A.To remove the catheter from the rectum, the retention cuff must be deflated.1) attach the 60ml syringe to the green inflation port, and slowly withdraw all water from the retention cuff.B.Make sure the inflation port remains parallel to the catheter in order to prevent kinking in the tubing and blockage of fluid.Refer to ideal patient positioning described in step 3a.1) once you have ensured the cuff is fully deflated, disconnect the syringe and discard.2) to facilitate removal, you may add an appropriate amount of lubricant to the anal sphincter prior to pulling back on the catheter to remove the cuff.3) grasp the catheter as close to the patient as possible and slowly slide the cuff out of the anus.Dispose of the device in accordance with institutional protocol for disposal of medical waste.11.System care, maintenance, and monitoring of device a.Take note of the black position indicator line that is printed in the proximal segment of the tsz.Observe its relative position to the patient¿s anus.Observe changes in the location of the position indicator band as a means to determine movement of the retention cuff in the patient¿s rectum.This may indicate the need for the cuff or drainage tube to be repositioned.B.Change the collection bag as needed.C.Secure the bag cap onto each used collection bag and discard according to institutional protocol for disposal of medical waste.D.To ensure unobstructed flow of fecal matter from the drainage tube to the collection bag, frequently verify that the catheter and collection bag are positioned so that the catheter is not twisted, kinked, or externally compressed.E.Frequently verify that waste is not accumulating in the catheter drainage tube.F.Verify patient is not lying on drainage tube or ports in such a manner as to potentially cause discomfort or localized prolonged pressure.G.Check the retention cuff volume regularly to ensure proper inflation." 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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