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

Device Problems Break (1069); Material Integrity Problem (2978); Material Twisted/Bent (2981)

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.

Event Description

It was reported that the wire from the temperature sensing catheter was distorted, wavy and poked through the rubber.Nursing staff stated that there may be potential damage to the urethra when removed.Per additional information received via email on (b)(6) 2018 from complainant, the catheter was in place for 3 days prior to removal.Reportedly, the patient yelled loudly when the catheter was removed.(b)(6) 2018.

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 lubri-sil foley catheter product ifus are found to be adequate based on past reviews.H3 other text : the device was not returned.

Event Description

It was reported that the wire from the temperature sensing catheter was distorted.It was wavy and poked through the rubber.Nursing staff stated that there may be potential damage to the urethra when removed.It was later reported via email on 20-dec.-2018 from the complainant that the catheter was in place for 3 days prior to removal.

• Brand Name: LUBRI-SIL FOLEY CATHETERS
• 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: 8205345
• MDR Text Key: 131780113
• Report Number: 1018233-2018-06283
• 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: consumer,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2018
• Initial Date FDA Received: 12/29/2018
• Supplement Dates Manufacturer Received: 03/28/2019
• Supplement Dates FDA Received: 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1