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

Device Problem Inaccurate Flow Rate (1249)

Patient Problems Abdominal Pain (1685); Urinary Retention (2119)

Event Date 03/26/2024

Event Type  Injury  

Event Description

It was reported that patient complained of severe abdominal pain.Patient had foley catheter but only scant amount of urine in foley drainage bag.Nurse bladder scanned patient which showed 900ml urine in bladder.Nurse removed water from foley balloon, and it only had 8ml, they replaced with 10ml, but catheter still did not drain out any urine.They attempted to deflate the foley balloon and was unable to do it.Balloon needed to be popped with guidewire by md which was successful.Patient was able to void 900ml plus after foley removed.Per customer follow up received on 01apr2024, it was reported that the physical sample was given to bd representative.Initial reporter states there was no patient involvement, catheter but being used on a mannequin.

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.

Event Description

It was reported that patient complained of severe abdominal pain.Patient had foley catheter but only scant amount of urine in foley drainage bag.Nurse bladder scanned patient which showed 900ml urine in bladder.Nurse removed water from foley balloon, and it only had 8ml, they replaced with 10ml, but catheter still did not drain out any urine.They attempted to deflate the foley balloon and was unable to do it.Balloon needed to be popped with guidewire by md which was successful.Patient was able to void 900ml plus after foley removed.Per customer follow up received on 01apr2024, it was reported that the physical sample was given to bd representative.Initial reporter states there was no patient involvement, catheter but being used on a mannequin.

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 user related (example: salt accumulation)/block drainage lumen/no drainage eye).The lot number is unknown; therefore, the device history record could not be reviewed.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.

• Brand Name: UNKNOWN LATEX FOLEY CATHETER
• Type of Device: 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: 19115292
• MDR Text Key: 340268655
• Report Number: 1018233-2024-02110
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• 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: 03/26/2024
• 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): Required Intervention