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

Model Number	421712
Health Effect - Clinical Code	Urinary Tract Infection (2120)
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 as a result of using the device, the patient has experienced a urinary tract infection.The patient also noted that the catheters were re-sterilized.
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 patient experienced a urinary tract infection while using the catheter.The patient reported that the catheters were re-sterilized.
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: "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." (b)(4).
Event or Problem Description
It was reported that the patient experienced a urinary tract infection while using the catheter.The patient reported that the catheters were re-sterilized.
Additional Manufacturer Narrative
No sample was returned for evaluation.Based on the investigation findings, current manufacturing controls are considered adequate as to detect and segregate any nonconforming unit.The event described was confirmed as use-related.The ifu states "do not re-sterilize any portion of this device." the root cause for this was due to the device being used improperly.The device was used in a manner for which it was not designed or approved for.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: "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." (b)(4).
Event or Problem Description
It was reported that the patient experienced a urinary tract infection while using the catheter.The patient reported that the catheters were re-sterilized.

• Brand Name: BARDIA® URETHRAL CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6841788
• Report Number: 1018233-2017-04598
• Device Sequence Number: 636958
• Product Code: KOD
• UDI-Device Identifier: 00801741038815
• UDI-Public: (01)00801741038815
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/17/2018

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 Expiration Date: 02/28/2021
• Device Model Number: 421712
• Device Catalogue Number: 421712
• Device Lot Number: NGAP3247
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 08/14/2017; 01/10/2018; 01/12/2018
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 09/07/2017; 01/11/2018; 01/17/2018
• 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: Other; Required Intervention