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

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Abdominal Pain (1685)

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.It was unknown whether the product had caused the reported failure.The potential root cause for this failure could be operator¿s error- missed plug the catheters into the spigot on the manifold and cause occluded drainage eye (reduced flow rate).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.

Event Description

It was reported that there was a regular problem with bard foley catheters for a while within the intensive care department.Stated that they were not draining properly (batch# unk) or were clogged (batch # unk) and therefore the patients got a full bladder.Last week, a patient who had 1300 cc in the bladder and had a catheter, when removed the balloon looked a bit strange (batch# unk).It went well for a while, but last fall they also had three patients (batch# unk).Per follow-up information received from (b)(6) on 13jul2023, stated that the balloon looked a bit strange meant that the balloon looked adhered and was also bloody but that could also be from the patient.For this case, they had now seen only one patient but the lot number could not be traced.As for the catheters that were not draining properly, they did not know the lot number or the number of patients that had this issue.However, they often had to siphon to empty the bladder properly, could be due to the catheter but also the urimeter.As for the catheters that were clogged, they did not had any idea about the lot number or the number of patients that had this issue.As for the previous problems, none were reported except for one that was.In that patient, it was typical that they did urinate 30-40 cc, but had abdominal pain.They took out the catheter and at that point the urine poured out and the abdominal pain disappeared.No medical intervention was reported.

• Brand Name: 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: 17443651
• MDR Text Key: 320251021
• Report Number: 1018233-2023-05731
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• 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: 07/13/2023
• 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