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

Model Number	177514
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the intermittent catheter tip was deformed in the sterile intermittent catheterization tray.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the intermittent catheter tip was deformed in the sterile intermittent catheterization tray.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.Visual evaluation noted 3 photo samples received.First photo shows catheter attached to bag.Second picture external packaging of catheter.Third picture zooms in on catheter tip showing it to be bent at the tip.Based on these pictures, product does not meet specifications.Although an exact root cause could not be determined a potential root cause could be operator error.The lot number was unknown; therefore, the device history record could not be reviewed.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 ef fects in experimental animals, notably liver toxicity and testicular atrophy.Although the toxic and carcinogenic ef fects of dehp have been well established in experimental animals, the ability of this compound to produce adverse ef fects 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 ef fect 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." corrections: g, 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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the intermittent catheter tip was deformed in sterile intermittent catheterization tray.

• Brand Name: BARD® UTIL-CATH¿ URETHRAL 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13447306
• Report Number: 1018233-2022-00371
• Device Sequence Number: 5210954
• Product Code: KOD
• UDI-Device Identifier: 00801741039003
• UDI-Public: (01)00801741039003
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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: Lay User/Patient
• Device Model Number: 177514
• Device Catalogue Number: 177514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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