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

Device Problem Burst Container or Vessel (1074)

Patient Problems Urinary Retention (2119); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/10/2021

Event Type  malfunction  

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.It is unknown whether the device had met relevant specifications.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be ¿short latex dwell time" or "latex dip speed out too slow" and might be user related (example: contact with sharp object/ exposure to petrolatum based products mechanical failure/operator error).The device was not returned for evaluation.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.

Event Description

It was reported that the patient experienced abdominal distension and difficulty in urinating while using the foley catheter on (b)(6) 2021.The nurse palpated the bladder area and they confirmed that the rupture of the foley catheter balloon.The foley catheter was extubated, and it was confirmed to be ruptured when after removal the foley catheter balloon.No medical intervention was reported.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12925405
• MDR Text Key: 283831830
• Report Number: 1018233-2021-07723
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 56 YR