Model Number 36301 |
Device Problems
Inaccurate Flow Rate (1249); Infusion or Flow Problem (2964)
|
Patient Problem
Urinary Tract Infection (2120)
|
Event Type
Injury
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.
|
|
Event Description
|
It was reported that the male external catheter would not drain properly.The urine pooled inside of the tip of the catheter in the amount of a tablespoon and.Allegedly, this caused the patient to inherit a uti (urinary tract infection) and was prescribed antibiotics.
|
|
Manufacturer Narrative
|
The reported event was unconfirmed.Visual evaluation noted 2 unopened unused male external catheters.Both catheters were rolled normal, and unrolled as intended according to the instructions.The id of the nozzle was measured (0.320" and 0.328") and was found to be in specification (0.33 +/-.01).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: "description/indication the self-adhering male external catheter is designed for the management of male urinary incontinence.Contraindication: do not use on irritated or compromised skin.Precaution: do not use if allergic reaction occurs.For good hygiene, change catheter daily.Use of a single device for longer periods than 24 hours may increase the risk of complications.Directions: to apply: wash penis with mild soap and warm water.Dry thoroughly.Trim pubic hair if necessary.Open package at perforation.To remove plastic insert, squeeze catheter at the top of the white cone and pull to release.Unroll self-adhering catheter over penis.Gently squeeze the catheter to properly seal adhesive to the skin.Connect to collection bag.Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin.Directions: to remove: gently roll catheter off the penis.Note: if necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive.".
|
|
Event Description
|
It was reported that the male external catheter would not drain properly.The urine pooled inside of the tip of the catheter in the amount of a tablespoon and.Allegedly, this caused the patient to inherit a uti (urinary tract infection) and was prescribed antibiotics.
|
|
Search Alerts/Recalls
|