MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® UTIL-CATH¿ URETHRAL CATHETER

Model Number	177514
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the catheter end was pointy and had a large opening.It was supposed to be closed with a rounded tip.
Event or Problem Description
It was reported that the catheter end was pointy and had a large opening.It was supposed to be closed with a rounded tip.
Additional Manufacturer Narrative
The reported event was confirmed.The device did not meet specifications.The product was intended to be used for treatment purposes.The product was influenced by the reported failure.Visual evaluation of the returned sample noted one unopened (inside original packaging), utili-cath urethral catheter.Visual inspection of the sample noted that while the packaging seal was complete with no voids, the catheter was damaged inside the packaging.The catheter tip was cut off below the eyelets.The cut was clean and listed at an angle.This is out of specification per inspection procedure, which states to check for, "tip and eye smoothness" although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿too high/too low viscosity.¿ 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: ¿bard® intermittent catheters manufacturer: c.R.Bard, inc.Covington, ga 30014 1-800-526-4455 www.Bardmedical.Com assembled in mexico instructions for use indications for use: for urological use only.Warnings: visually inspect the product for any imperfections or surface deterioration prior to use.Some intermittent catheters may contain or have presence of phthalates: di(2-ethylhexyl)phthalate (dehp) is a plasticizer used in some polyvinyl chloride medical devices.Dehp has been shown to produce a range of adverse effects in experimental animals, notably liver toxicity and testicular atrophy.Although the toxic and carcinogenic effects of dehp have been well established in experimental animals, the ability of this compound to produce adverse effects in humans is controversial.There is no evidence that neonates, infants, pregnant and breast feeding women exposed to dehp experience any related adverse effects.However, a lack of evidence of causation between dehp-pvc and any disease or adverse effect does not mean that there are no risks.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 failure, and/or to injury , illness or death of the patient.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Adverse reactions: urinary tract infection.Bleeding from the urethra.Irritation of the urethra.Instructions for intermittent catheters: 1.Wash your hands thoroughly with soap and water.2.Remove catheter from the pack.3.Position yourself comfortably, cleaning the opening of the urethra and surrounding area.4.Gently insert rounded end of catheter into urethra.5.When urine stops flowing, remove catheter from urethra.6.Dispose of catheter in accordance with local rules and regulations.7.Wash your hands.Caution: federal (u.S.A.) laws restricts this device to sale by or on the order of a physician.Single-use.Single patient use, do not reuse.Do not use if package is opened or damaged.Pk7639305 06/2015 bard, clean-cath and util-cath are trademarks and/or registered trademarks of c.R.Bard, inc.© 2015.C.R.Bard, inc." 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.

• Brand Name: BARD® UTIL-CATH¿ URETHRAL CATHETER
• Common Device Name: URETHRAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9915444
• Report Number: 1018233-2020-02261
• Device Sequence Number: 14296556
• Product Code: KOD
• UDI-Device Identifier: 00801741039003
• UDI-Public: (01)00801741039003
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 177514
• Device Catalogue Number: 177514
• Device Lot Number: NGCN3944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 05/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1