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

Catalog Number UNKNOWN

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Urinary Retention (2119)

Event Date 02/02/2022

Event Type  malfunction  

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 Description

It was reported that the foley temperature sensing catheters were not draining appropriately and resulted in significant retention in two patients.Customer stated that they were diligent about positioning the catheter to avoid kinks or occlusions.One patient had statlock in place, but the other did not have it.Customer mentioned that it was not just a little retention.One of the patients was consulted renal for an elevated creatinine.There were no obvious defects found when the catheter was exchanged and the catheter itself looked patent.The second patient had some significant chugging or elevated venous drainage pressures (ecmo) related to bladder distention.It was further reported that few other nurses have faced similar issues where they had to exchange the foley catheter and 2 liters of urine drained.This also happened last night for retention issues with bard foley catheter.No medical intervention was reported.

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).A dhr review is not required as the lot number is unknown.Therefore, no additional action required at this time.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the foley catheter fus 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.

Event Description

It was reported that the foley temperature sensing catheters were not draining appropriately and resulted in significant retention in two patients.Customer stated that they were diligent about positioning the catheter to avoid kinks or occlusions.One patient had statlock in place, but the other did not have it.Customer mentioned that it was not just a little retention.One of the patients was consulted renal for an elevated creatinine.There were no obvious defects found when the catheter was exchanged and the catheter itself looked patent.The second patient had some significant chugging or elevated venous drainage pressures (ecmo) related to bladder distention.It was further reported that few other nurses have faced similar issues where they had to exchange the foley catheter and 2 liters of urine drained.This also happened last night for retention issues with bard foley catheter.No medical intervention was reported.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13605588
• MDR Text Key: 286277630
• Report Number: 1018233-2022-00892
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• 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