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

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Tissue Damage (2104)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the catheter was too stiff, which allegedly caused the catheter to go through the posterior wall of the urethra during insertion.The tissue damage that was observed was an opening in the posterior urethral wall.The physician believed that the tissue damage was caused by the catheter being too stiff.

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 temperature sensing catheter product ifus are found to be adequate based on past reviews.(b)(4).The information provided by bard 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 bard.The device was not returned.

Event Description

It was reported that the catheter was too stiff, which allegedly caused the catheter to go through the posterior wall of the urethra during insertion.The tissue damage that was observed was an opening in the posterior urethral wall.The physician believed that the tissue damage was caused by the catheter being too stiff.It was later reported, the physician had to perform a cystoscopy to place another catheter around the tissue damage.

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 was too stiff, which allegedly caused the catheter to go through the posterior wall of the urethra during insertion.The tissue damage that was observed was an opening in the posterior urethral wall.The physician believed that the tissue damage was caused by the catheter being too stiff.Per additional information received, the physician had to perform a cystoscopy to place another catheter around the tissue damage.

• Brand Name: SPECIALTY FOLEYS
• Type of Device: TEMP SENSING CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7321786
• MDR Text Key: 101796850
• Report Number: 1018233-2018-00726
• 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,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/07/2018
• Supplement Dates Manufacturer Received: 03/07/2018; 03/13/2018
• Supplement Dates FDA Received: 03/09/2018; 03/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 23 YR