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

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/05/2024

Event Type  Injury  

Event Description

It was reported that patient with spina bifida to emergency department with urinary tract infection.Indwelling catheter removed was gunky.Bardex all-silicone foley catheter inserted and drained 20cc.Bladder scan revealed 160cc in bladder and attempted to irrigate catheter without success.Foley was removed and another one tried, drained dark red urine with small clot and there was no known harm to patient.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a: through f: the information provided by bd represents all 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.

• Brand Name: ALL SILICONE CATHETER
• Type of Device: SILICONE 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18845546
• MDR Text Key: 337000889
• Report Number: 1018233-2024-01151
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/06/2024
• 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): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 109 KG