MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® INTERGLIDE¿ INTERMITTENT CATHETER

Model Number	431616
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when asked of unexpected challenges while using the intermittent catheter, the respondent said, urinary tract trauma.It was unknown what medical intervention was provided for urinary tract trauma.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "improper surface treatment via chlorination".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: 1.Wash your hands with soap and water, and wash your genitalia using either soap and water or a wet wipe.2.Open the interglidet packaging at the funnel end by approximately 2-3 cm.Run water from the cold tap into the sachet and wait for at least 30 seconds.3.Place yourself in the most comfortable position.Try sitting on the toilet or stand in front of it.Remember if you do not sit on the toilet you will need a jug or bowl for the urine.4.With one hand, pull back the foreskin and hold your penis upwards to straighten the ¿s¿ bend.Take care not to press too tightly or the urethra will be blocked.5.Holding the penis in an upright position, gently insert interglidetm until it reaches the bladder and urine flows.Whilst inserting interglidetm you may find that pretending to pass urine or coughing helps if you feel any resistance.Never force the catheter in.6.Once your bladder is empty and urine stops flowing, slowly remove interglidetm.If the flow restarts, stop withdrawing until the bladder is empty.7.When you have finished, place interglidetm back in the outer wrapper and dispose of in a rubbish bin.Wash your hands with soap and water.Female - english 1.Wash your hands with soap and water, and wash your genitalia using either soap and water or a wet wipe.2.Open the interglidetm packaging at the funnel end by approximately 2-3 cm.Run water from the cold tap into the sachet and wait for at least 30 seconds.3.Place yourself in the most comfortable position.You can try sitting on the toilet with your legs apart, standing with one leg slightly raised, squatting against a wall or lying down with your knees bent and legs apart.Remember if you do not sit on the toilet, you will need a jug or bowl for the urine.4.Part the labia with your index and the middle finger of one hand.In the beginning you may find using a mirror helpful.5.Hold interglidetm in your other hand and gently insert it into the urethral opening until it reaches the bladder and urine flows.When inserting interglidetm, don't forget to bend the open funnel end down towards the toilet bowl or jug.6.Once your bladder is empty and urine stops flowing, slowly remove interglidetm.If the flow restarts, stop withdrawing until the bladder is empty.7.When you have finished, place interglidetm back in the outer wrapper and dispose of in a rubbish bin.Wash your hands with soap and water.'' correction: h 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.
Event or Problem Description
It was reported that when asked of unexpected challenges while using the intermittent catheter, the respondent said, urinary tract trauma.It was unknown what medical intervention was provided for urinary tract trauma.

• Brand Name: BARD® INTERGLIDE¿ INTERMITTENT CATHETER
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13497853
• Report Number: 1018233-2022-00491
• Device Sequence Number: 4704640
• Product Code: KOD
• UDI-Device Identifier: 00801741078040
• UDI-Public: (01)00801741078040
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K951260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 431616
• Device Catalogue Number: 431616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown