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

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problems Hemorrhage/Bleeding (1888); Patient Problem/Medical Problem (2688)

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 catheter "snaked" while it was still inside of the patient.The patient reportedly experienced self-limited bleeding.No medical intervention was required.Additional information was received from the complainant via email on 29jan2019, that the hard ridges were observed on the catheter during shift assessment.The complainant noted that the temp probe seemed to have "bunched up" within the catheter, causing the hard ridges.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product family is unknown, the specialty foleys product ifus are found to be adequate based on past reviews.

Event Description

It was reported that the catheter "snaked" while it was still inside of the patient.The patient reportedly experienced self-limited bleeding.No medical intervention was required.Additional information was received from the complainant via email on 29jan2019, that the hard ridges were observed on the catheter during shift assessment.The complainant noted that the temp probe seemed to have "bunched up" within the catheter, causing the hard ridges.

• 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: 8344486
• MDR Text Key: 136602912
• Report Number: 1018233-2019-00846
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• 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: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1