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

Model Number	119112
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the water could be drained only halfway when the user tried to remove the water from the foley catheter during the pretest.About 2 ml of water was aspirated by syringe.It was stated that the user tried to deflate using syringe but the balloon was partially deflated and the catheter could be removed.Completely.Usually, balloon can be deflated within a few seconds.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event was confirmed and the cause was unknown.The potential failure modes are collapsed lumen and blocked lumen.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "[warnings].1.Method for use.(1) do not inflate the balloon in the urethra.[the urethra may be injured.] (2) do not pull the catheter hard.[the bladder/urethra may be injured.] 2.Applicable patients.Patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] [contraindications].1.Method for use: (1) do not reuse.(2) do not resterilize.(3) this device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (5) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients.Patients with known allergy to silver coated catheter".H11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the water could be drained only halfway when the user tried to remove the water from the foley catheter during the pretest.About 2 ml of water was aspirated by syringe.It was stated that the user tried to deflate using syringe but the balloon was partially deflated and the catheter could be removed completely.Usually, balloon can be deflated within a few seconds.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16060966
• Report Number: 1018233-2022-09902
• Device Sequence Number: 6639728
• Product Code: EZL
• UDI-Device Identifier: 00801741046018
• UDI-Public: (01)00801741046018
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070582
• 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): 03/15/2023

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: 119112
• Device Catalogue Number: 119112
• Device Lot Number: NGGP1733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• 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