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

Model Number	421614
Medical Device Problem Codes	Use of Device Problem (1670); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2020
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 the patient noticed after four months of buying the clean cath vinyl catheter the plastic was allegedly not smooth and instead it was sticky.
Additional Manufacturer Narrative
The reported event was confirmed as use related.Visual evaluation of the returned sample noted 43 unopened (within original packaging), unused clean cath vinyl catheters.Visual inspection of the sample noted no obvious visible defects.8 samples were tested.The catheter shafts were rubbed and felt normal and smooth as intended.The root cause of this failure is that the user used an expired product.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.Caution: federal (usa) law restricts this device to sale by or on the order of a physician.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 patient noticed after four months of buying the clean cath vinyl catheter the plastic was allegedly not smooth and instead it was sticky.Per evaluation, the patient has used expired product often.

• Brand Name: BARD CLEAN-CATH CATHETER
• Common Device Name: CLEAN CATH CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10837171
• Report Number: 1018233-2020-20942
• Device Sequence Number: 14327878
• Product Code: KOD
• UDI-Device Identifier: 00801741038976
• UDI-Public: (01)00801741038976
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K802665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: 08/31/2020
• Device Model Number: 421614
• Device Catalogue Number: 421614
• Device Lot Number: NGZH1224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 04/18/2021
• 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