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

Device Problem Inaccurate Information (4051)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2022

Event Type  malfunction  

Event Description

It was reported that the survey respondent stated no, the instructions for use (ifu) did not provide sufficient information about the product and its medical application when asked if they would agree with the statement: the instructions for use (ifu) for the following bard / becton dickinson product(s) provides sufficient information about the product(s) and its/their medical application(s) in relation to bardex® i.C.Female length, 2-way foley catheter, no french size specified.And informed that in their opinion the ifu did not provide sufficient information about the product previously mentioned and its medical application because of expiration date error, illegible information, inaccurate information, unclear information, missing information, lack of maintenance documentation or guidelines, inadequate instructions for healthcare processional and inadequate or insufficient training.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.It was 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.A potential root cause for this failure could be illegible print & missing print.The device was not returned for evaluation.The lot number is unknown.Therefore, the device history record could not be reviewed.The instructions for use were found adequate and states it was unable to review the labelling due to unknown product code.Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.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.

Event Description

It was reported that the survey respondent stated no, the instructions for use (ifu) did not provide sufficient information about the product and its medical application when asked if they would agree with the statement: the instructions for use (ifu) for the following bard / becton dickinson product(s) provides sufficient information about the product(s) and its/their medical application(s) in relation to bardex® i.C.Female length, 2-way foley catheter, no french size specified.And informed that in their opinion the ifu did not provide sufficient information about the product previously mentioned and its medical application because of expiration date error, illegible information, inaccurate information, unclear information, missing information, lack of maintenance documentation or guidelines, inadequate instructions for healthcare processional and inadequate or insufficient training.

• Brand Name: UNKNOWN LATEX FOLEY CATHETER
• Type of Device: LATEX 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15753774
• MDR Text Key: 307305248
• Report Number: 1018233-2022-08591
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female