MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SPECIALTY FOLEYS; TEMPERATURE SENSING FOLEY CATHETER

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310); Device Damaged Prior to Use (2284); Obstruction of Flow (2423); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 16 temperature sensing catheters had issues.7 of the catheter's temperature wires appeared to be bunched up, which resulted in not draining properly.The foleys were discontinued by the rn on duty.Another 8 of the temperature sensing foleys looked distorted and unable to insert because they did not appear to be smooth at the tip.The final foley was determined to have an asymmetrical balloon when the balloon was inflated outside the patient.Also, many of the foleys leaked from the sample port.The nursing staff was concerned that any of these issues may result in trauma to the patient upon insertion and may contribute to an uti.No medical intervention was reported.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review could not be completed due to no product catalog # provided and there was not enough information to determine the labeling to be inadequate.H11:section a through f - the information provided by bd represents all of 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 16 temperature sensing catheters had issues.7 of the catheter's temperature wires appeared to be bunched up, which resulted in not draining properly.The foleys were discontinued by the rn on duty.Another 8 of the temperature sensing foleys looked distorted and unable to insert because they did not appear to be smooth at the tip.The final foley was determined to have an asymmetrical balloon when the balloon was inflated outside the patient.Also, many of the foleys leaked from the sample port.The nursing staff was concerned that any of these issues may result in trauma to the patient upon insertion and may contribute to an uti.No medical intervention was reported.

• Brand Name: SPECIALTY FOLEYS
• Type of Device: TEMPERATURE SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8354664
• MDR Text Key: 137078922
• Report Number: 1018233-2019-00891
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1