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

Model Number	421714
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional 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.The device was not returned.
Event or Problem Description
It was reported that the catheter broke 5-6 inches from the tip inside the patient's urethra.Allegedly, a surgical procedure was required to the remove the broken piece of the catheter.Per additional information received via phone on (b)(6) 2018, the patient allegedly used fingernail clippers to intentionally break the catheter prior to insertion in his urethra.The complainant stated that they believe the break was done by the patient purposefully so that he could be escorted from the penitentiary to spend time in the hospital where there is air conditioning and a comfortable bed.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use was found adequate and states the following: "bard® clean-cath® sterile catheter for intermittent catheterization.Visually inspect the product for any imperfections or surface deterioration prior to use.Latex-free sterilized using ethylene oxide length unisex female for urological use only.To use: insert rounded end of catheter.Caution: federal (usa) law restricts this device to sale by or on the order of a physician.Contains or 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.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.This is a single use device.Do not re-sterilize 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 device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Single use do not resterilize catalog number do not use if package is damaged caution, consult accompanying documents.Units bard and clean-cath are trademarks and/or registered trademarks of c.R.Bard, inc.Manufacturer: c.R.Bard, inc.Covington, ga 30014 usa 1-800-526-4455 www.Bardmedical.Com assembled in mexico bard limited forest house (b)(4).Patient code: (b)(6).
Event or Problem Description
It was reported that the catheter broke 5-6 inches from the tip inside the patient's urethra.Allegedly, a surgical procedure was required to the remove the broken piece of the catheter.Per additional information received via phone on (b)(6)2018 , the patient allegedly used fingernail clippers to intentionally break the catheter prior to insertion in his urethra.The complainant stated that they believe the break was done by the patient purposefully so that he could be escorted from the penitentiary to spend time in the hospital where there is air conditioning and a comfortable bed.

• Brand Name: BARD® CLEAN-CATH® INTERMITTENT CATHETER
• Common Device Name: CLEAN CATH VINYL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7838593
• Report Number: 1018233-2018-03905
• Device Sequence Number: 19441396
• Product Code: KOD
• UDI-Device Identifier: 00801741038822
• UDI-Public: (01)00801741038822
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K802665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 421714
• Device Catalogue Number: 421714
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention