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

Model Number	420718
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 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 the patient used a catheter that expired in 2017.Per additional information, the product was already expired before it was shipped to the patient.
Event or Problem Description
It was reported the patient used a catheter that expired in 2017.It was later reported the product was already expired before it was shipped to the patient.
Additional Manufacturer Narrative
The reported issue (it was reported that the catheter that the patient used had expired in 2017.Per additional information, the product was already expired before it was shipped to the patient) was confirmed.During the visual inspection it was confirmed that product was expired, the five samples received had expiration date 6-2017 printed in the package.According to product structure applicable to the part number 420718 specify that "the expiration date is 5 years from the month when it was packaged".The production date was reviewed in the dhr and the lot was produced on 6-08-2012.According this information the product was manufactured with correct expiration date "5 yeas", as is specified in the product structure.By condition of the samples determined to be the result of post-manufacturing damage and outside the control of manufacturing.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿bard clean-cath sterile catheter for intermittent catheterization.Visually inspect the product for any imperfections or surface deterioration prior to use.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.".
Event or Problem Description
It was reported the patient used a catheter that expired in 2017.Per additional information, the product was already expired before it was shipped to the patient.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿bard clean-cath sterile catheter for intermittent catheterization.Visually inspect the product for any imperfections or surface deterioration prior to use.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.".

• 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: 7392935
• Report Number: 1018233-2018-01026
• Device Sequence Number: 334276
• Product Code: KOD
• UDI-Device Identifier: 00801741038761
• UDI-Public: (01)00801741038761
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K802665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2018

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 Expiration Date: 06/30/2017
• Device Model Number: 420718
• Device Catalogue Number: 420718
• Device Lot Number: NGWE3688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Initial Date Received by Manufacturer: 03/10/2018
• Supplement Date Received by Manufacturer: 04/11/2018; 05/30/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 04/12/2018; 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1