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

Device Problems Infusion or Flow Problem (2964); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem Discomfort (2330)

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 foley catheter was placed in the or without difficulty and then later was noted to not drain once the patient reached the floor.The patient was reportedly voiding around the catheter and the decision was made to remove and replace it.They could not get it out and were met with resistance despite emptying all fluid from balloon.When it eventually was removed there was a knot near the end of the tube.The catheter was reportedly replaced.Per additional information received via email from the complainant on 27jan2020, the balloon was believed to have been inflated with 1.5ml of sterile water, and all the fluid retained when the balloon was deflated.The patient reportedly experienced some discomfort.No medical intervention was reported.

Manufacturer Narrative

The reported event was confirmed, however, the cause is unknown.Visual evaluation of the returned sample noted one opened (without original packaging), silicone foley catheter.Visual inspection of the sample noted a knot in the catheter shaft at the balloon top.The knot was removed and the catheter shaft remained bent/curved.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿operator error." the lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.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.

Event Description

It was reported that the foley catheter was placed in the or without difficulty and then later was noted to not drain once the patient reached the floor.The patient was reportedly voiding around the catheter and the decision was made to remove and replace it.They could not get it out and were met with resistance despite emptying all fluid from balloon.When it eventually was removed there was a knot near the end of the tube.The catheter was reportedly replaced.Per additional information received via email from the complainant on 27jan2020, the balloon was believed to have been inflated with 1.5ml of sterile water, and all the fluid retained when the balloon was deflated.The patient reportedly experienced some discomfort.No medical intervention was reported.

• Brand Name: ALL SILICONE CATHETER
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9699275
• MDR Text Key: 183549170
• Report Number: 1018233-2020-00964
• 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: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Date Manufacturer Received: 03/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1