MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LATEX FOLEY CATHETER; UNKNOWN FOLEY CATHETER

Model Number	0168L22
Medical Device Problem Code	Inadequate or Insufficient Training (1643)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2022
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 device was not returned.
Event or Problem Description
It was reported that the survey respondent stated no, they did not agree that the instructions for use (ifu) for the following bard/becton dickinson products provides sufficient information about the products and its medical application because the instructions for use (ifu) had inadequate or insufficient training in relation to biocath foley catheter preconnected to a urine meter, female length, no french size specified.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.The potential root cause for this failure could be due to incorrect translation or inadequate instructions.The dhr review could not be performed without a lot number.Therefore, no additional action is required at this time.The product catalog number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.H11: section a through f - the information provided by bd represents all 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.
Event or Problem Description
It was reported that the survey respondent stated no, they did not agree that the instructions for use (ifu) for the following bard/becton dickinson products provides sufficient information about the products and its medical application because the instructions for use (ifu) had inadequate or insufficient training in relation to biocath foley catheter preconnected to a urine meter, female length, no french size specified.
Event or Problem Description
It was reported that the survey respondent stated no, they did not agree that the instructions for use (ifu) for the following bard/becton dickinson products provides sufficient information about the products and its medical application because the instructions for use (ifu) had inadequate or insufficient training in relation to biocath foley catheter preconnected to a urine meter, female length, no french size specified.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 device was not returned.

• Brand Name: LATEX FOLEY CATHETER
• Common Device Name: UNKNOWN FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16094858
• Report Number: 1018233-2022-10175
• Device Sequence Number: 6703785
• Product Code: EZC
• UDI-Device Identifier: 00801741017858
• UDI-Public: (01)00801741017858
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2023

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 Model Number: 0168L22
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 12/19/2022; 03/03/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 01/09/2023; 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown