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

Catalog Number UNKNOWN

Device Problems Deflation Problem (1149); Material Puncture/Hole (1504); Device Fell (4014)

Patient Problem Urinary Retention (2119)

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 balloon of the foley had a hole in it and subsequently fell out of the patient.No medical intervention was reported.Per additional information received on (b)(6) 2018 from complainant via email, it was noted that the foley was placed in the or during the procedure.The physician and pacu nurse were concerned that the patient wasn¿t producing urine as there was no output through the catheter/bag.They gave 2 different boluses assuming the patient was dry.Eventually through their assessments and troubleshooting, they found the catheter was not in its original placement in the bladder.Once they placed another catheter, over 900ml of urine back as return.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.We were unable to review the labeling due to unknown product code.Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.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 balloon of the foley had a hole in it and subsequently fell out of the patient.No medical intervention was reported.Per additional information received on december 28, 2018 from complainant via email, it was noted that the foley was placed in the or during the procedure.The physician and pacu nurse were concerned that the patient wasn¿t producing urine as there was no output through the catheter/bag.They gave 2 different boluses assuming the patient was dry.Eventually through their assessments and troubleshooting, they found the catheter was not in its original placement in the bladder.Once they placed another catheter, over 900ml of urine back as return.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8231992
• MDR Text Key: 132569139
• Report Number: 1018233-2019-00192
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• 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: 01/10/2019

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
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/09/2019
• Supplement Dates Manufacturer Received: 01/10/2019
• Supplement Dates FDA Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1