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

Device Problems Physical Resistance (2578); Mushroomed (2987)

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 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 nurse was discontinuing a foley on a male patient, and attached a syringe to the balloon port and the water came back out of the balloon with no issue (5cc).When they went to remove the catheter, they were met with resistance and could not pull out the catheter.They tried all of the tips and tricks noted on the removal poster, thinking that maybe there was still more water in the balloon causing the issue, but no additional water was found and they were still unable to remove.The complainant also reported that upon removal of the water, sometimes the balloon flattens itself into a pancake shape, instead of remaining round.There was 1ml of water reportedly inserted back into the balloon and was easily able to remove the catheter.

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 catalog number is unknown, the silicone catheter product ifus are found to be adequate based on past reviews.

Event Description

It was reported that the nurse was discontinuing a foley on a male patient, and attached a syringe to the balloon port and the water came back out of the balloon with no issue (5cc).When they went to remove the catheter, they were met with resistance and could not pull out the catheter.They tried all of the tips and tricks noted on the removal poster, thinking that maybe there was still more water in the balloon causing the issue, however no additional water was found and they were still unable to remove.The complainant also reported that upon removal of the water, sometimes the balloon flattens itself into a pancake shape, instead of remaining round.There was 1ml of water reportedly inserted back into the balloon and was easily able to remove the catheter.

• Brand Name: ALL SILICONE CATHETER
• Type of Device: SILICONE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 7570125
• MDR Text Key: 110268924
• Report Number: 1018233-2018-02076
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 06/21/2018
• Supplement Dates FDA Received: 06/26/2018
• 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