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

Catalog Number UNKNOWN

Device Problems Burst Container or Vessel (1074); Material Rupture (1546); Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problem Abdominal Distention (2601)

Event Date 08/27/2020

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 urinary catheter had ruptured and the catheter slipped out.After the doctor ordered the catheter to be re-indwelled, the catheter was then smooth and light red.Per additional information received via mail on 07sep2020, there were no missing pieces of the catheter.It was reported that this patient underwent the right ureteroscope inspection under general anesthesia on (b)(6).The continuous drop-based flushing was conducted on a triple-lumen urethral catheter at a rate of around 80 drops per minute.On (b)(6) 2020, this patient developed abdominal distension when lying on bed.The nurse found that the urethral catheter balloon ruptured and fell off on its own.After the problem occurred, a new urethral catheter was placed on the order of a doctor.The detached balloon and the catheter were complete.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.Potential root cause for this failure mode could be uneven sac thickness/overinflated.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the latex foley catheter product ifus were found to be adequate based on past reviews.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 urinary catheter had ruptured and the catheter slipped out.After the doctor ordered the catheter to be re-indwelled, the catheter was then smooth and light red.Per additional information received via mail on 07sep2020, there were no missing pieces of the catheter.The patient underwent the right ureteroscope inspection under general anesthesia on (b)(6).The continuous drop-based flushing was conducted on a triple-lumen urethral catheter at a rate of around 80 drops per minute.On (b)(6) 2020, this patient developed abdominal distension when lying on bed.The nurse found that the urethral catheter balloon ruptured and fell off on its own.After the problem occurred, a new urethral catheter was placed on the order of a doctor.The detached balloon and the catheter were complete.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10574051
• MDR Text Key: 208761091
• Report Number: 1018233-2020-06161
• 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
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• 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
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1