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

Model Number	421714
Medical Device Problem Codes	Material Fragmentation (1261); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/24/2021
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.
Event or Problem Description
It was reported that there was a tear and rip at the insertion end of the catheter and alleged patient urethra.The problem was identified due to the amount of blood loss prior going to the emergency department.The user had excessive bleeding and believe it was healed.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for treatment.The product caused the reported failure.Visual evaluation of the photo sample noted one opened (without original packaging), vinyl intermittent catheter.Visual inspection of the sample noted that the tip was broken off at one of the drainage eyes and the other portion of the tip was missing.This does not meet the specification "tips must be molded completely with no voids.".A potential root cause for this failure could be "defective material mixed in the raw material lot from supplier¿.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: "visually inspect the product for any imperfections or surface deterioration prior to use.To use: insert rounded end of catheter.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." 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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the catheter had a tear or rip at the insertion end.The customer complained that the catheter tore the patient's urethra and the patient had to go to the emergency department.The problem was identified due to the amount of blood loss prior going to the emergency department.The patient had excessive bleeding.The patient was on blood thinners and they believed that it was healed.

• Brand Name: BARD CLEAN-CATH INTERMITTENT CATHETER
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11842012
• Report Number: 1018233-2021-02881
• Device Sequence Number: 17194366
• Product Code: KOD
• UDI-Device Identifier: 00801741038822
• UDI-Public: (01)00801741038822
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K802665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 06/30/2025
• Device Model Number: 421714
• Device Catalogue Number: 421714
• Device Lot Number: NGET3392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: 04/24/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 11/01/2021
• 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