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

Catalog Number UNKNOWN

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Urinary Retention (2119)

Event Date 09/28/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the customer had issues that two of the foley catheters were not draining during the case.It was noted upon insertion that they had urine return, but no drainage during the case.Customer explained that they had another two situations recently that no urine output was noted during the case, then postoperatively they had bladder retention.In either instance, there were no indications during placement as urine return and no difficulties.When adjusting the foley, checking for kinks, checking for air lock, and it did not yield urine return in either case.Then the customer placed a new foley catheter, and it worked fine.It was further reported that the customer switched to a kit with swabs when they poured betadine on, but now getting the cotton balls in the kits like we had in the past.The representative advised that it was back order substitution for the 14 fr operating room insertion kits.It was stated that the leg bag customer was trialling for the rehab hospital that had good reviews except for the tubing being too long as it was currently 18 inches.Customer suggested connecting the leg bag directly to the foley catheter to make it shorter, and concerned that urine reflux into the bladder when the foley was attached directly to the leg bag.No medical intervention was reported.Per additional information received on 10oct2021, customer indicated to use the smallest catheter diameter that was appropriate and educated to this and had tried to switch to the 14 fr catheters, with supply limitations.Customer had found on the instructions for use that was inserted in the leg bag kit, and it stated that the leg bag has a flutter valve that acted like an antireflux feature, as well as the instructions stating that could connect it directly to the foley.

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 ifus are found to be adequate based on past reviews.The device was not returned.

Event Description

It was reported that the customer had issues that two of the foley catheters were not draining during the case.It was noted upon insertion that they had urine return, but no drainage during the case.Customer explained that they had another two situations recently that no urine output was noted during the case, then postoperatively they had bladder retention.In either instance, there were no indications during placement as urine return and no difficulties.When adjusting the foley, checking for kinks, checking for air lock, and it did not yield urine return in either case.Then the customer placed a new foley catheter, and it worked fine.It was further reported that the customer switched to a kit with swabs when they poured betadine on, but now getting the cotton balls in the kits like we had in the past.The representative advised that it was back order substitution for the 14 fr operating room insertion kits.It was stated that the leg bag customer was trialling for the rehab hospital that had good reviews except for the tubing being too long as it was currently 18 inches.Customer suggested connecting the leg bag directly to the foley catheter to make it shorter, and concerned that urine reflux into the bladder when the foley was attached directly to the leg bag.No medical intervention was reported.Per additional information received on 10oct2021, customer indicated to use the smallest catheter diameter that was appropriate and educated to this and had tried to switch to the 14 fr catheters, with supply limitations.Customer had found on the instructions for use that was inserted in the leg bag kit, and it stated that the leg bag has a flutter valve that acted like an antireflux feature, as well as the instructions stating that could connect it directly to the foley.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: UNKNOWN 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12657902
• MDR Text Key: 277186550
• Report Number: 1018233-2021-06478
• 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: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• 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: 10/25/2021
• 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