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

Model Number	175806N
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that urine was noted to be draining from balloon port of foley catheter.So, the user attempted to aspirate from balloon port for small amount of urine.When the foley catheter was removed, the balloon was found to be ruptured and had sediments on the tip.Another foley catheter was placed with no complications.The user was not able to determine whether parts of balloon remained inside the patient.It was stated the balloon material appeared to be intact.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be ¿balloon not completely sealed to shaft ¿.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "indications for use: the bardex® lubri-sil® all-silicone lubricious coated foley catheter 6 fr is indicated for use in the drainage and/or collection and/or measurement of urine.Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage catheter and may cause the balloon to burst.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Sterile unless package is opened or damaged.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities 1.5cc balloon: use 1.5cc sterile water do not exceed recommended capacities.Note: aggressive traction, particularly in the presence of suturing, is not recommended for silicone foley catheters.¿ correction: g 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.The device was not returned.
Event or Problem Description
It was reported that urine was noted to be draining from balloon port of foley catheter.So, the user attempted to aspirate from balloon port for small amount of urine.When the foley catheter was removed, the balloon was found to be ruptured and had sediments on the tip.Another foley catheter was placed with no complications.The user was not able to determine whether parts of balloon remained inside the patient.It was stated the balloon material appeared to be intact.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Common Device Name: 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14141222
• Report Number: 1018233-2022-02679
• Device Sequence Number: 14526504
• Product Code: EZL
• UDI-Device Identifier: 00801741034268
• UDI-Public: (01)00801741034268
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

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
• Operator of Device: Health Professional
• Device Model Number: 175806N
• Device Catalogue Number: 175806N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown