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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
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The reported event was confirmed cause unknown.Three all silicone foley catheter attached to the drainage bag were received.Per visual inspection it was evident that the inflation port was melted.This is out of specification as which states: "catheter must not be stretched, wrinkled or deformed.Contamination is not allowed in the catheter." although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be incorrect operation.However, there was insufficient information to confirm this potential root cause.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: "statlock® foley catheter stabilisation device kit uro-prep® tray with: 2 - gloves (not made with natural rubber latex).1 - fenestrated drape.5 - gauze squares (7.5 cm x 7.5 cm).1 - underpad.1 - 10 ml syringe, filled with water soluble lubricating gel.1 - 10 ml syringe, filled with sterile water (only for inflating the catheter).1 - 10 ml syringe, empty (only for deflating the catheter).2 - 10 ml syringe, filled with sterile water (for cleansing purposes only).Sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.This is a single use device.Do not resterilise any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws, regulations, and policies.Directions for use: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.1.Open outer white wrapping to prepare sterile field and place underpad beneath patient, plastic side down.2.If patient has a catheter in-situ to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, reseat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.Wait at least 30 seconds for deflation.If permitted by local protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance as directed by local protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.3.Put on gloves, cover patient with fenestrated drape with open exposing location where catheter will be inserted, and place the apron on yourself.4.Using the two (2) syringes, marked ¿for cleansing purposes only¿, dispense the water onto three (3) gauze squares.Prepare the patient by wiping down the catheter insertion site with the saturated gauze squares.Dry patient with the remaining two (2) gauze squares.Note: do not use this syringe to inflate the catheter balloon.5.Prepare the lubricating gel syringe by removing the cap from the syringe tip.6.For easing with the insertion of the catheter into the patient dispense the lubricating gel into the urethra (according to local protocol).7 remove top tray and open plastic pouch (sleeve) surrounding the catheter.8.Proceed with catheterisation according to local protocol.To inflate catheter, simply insert tip of sterile water-filled syringe gently into valve (do not overpenetrate) and depress plunger.Instill entire amount of sterile water - 10 ml.9.Attach statlock® foley stabilisation device to the bifurcation (y-shape) of the foley catheter (statlock® foley stabilisation device can be used for up to 7 days) and apply.(refer to the instructions for use provided with the statlock® foley stabilisation device pouch for more details).10.If the procedure pack includes a leg bag, utilise the leg straps provided to secure the leg bag to the patient¿s leg, making sure not to affect circulation or drainage of urine.11.Ensure catheter and drainage bag tubing is kink free and drainage bag is positioned below the bladder to ensure urine is flowing freely.Periodic inspection of this system should be made to ensure that urine is flowing freely.If a standing column of urine is observed, check for correct positioning of bag and then for a physical obstruction.If correct positioning or removal of physical obstruction does not allow free flow, further investigation should be taken in line with local protocol" 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.
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