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

Model Number 165816

Device Problems Material Protrusion/Extrusion (2979); Sharp Edges (4013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2022

Event Type  malfunction  

Event Description

It was reported that the foley catheter with extra piece at tip noted on removal-pcn#(b)(4).Per sample received on 01nov2022, it was noted that the returned sample was pcn#(b)(4).

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

The reported event was confirmed cause unknown.One sample exhibited the reported failure.The device had not met specifications.The reported failure is considered out of specification as the reported failure was reproduced.It is unknown if the product was used for patient treatment or diagnosis.The product caused the reported failure.Although the product was not returned, a potential root cause for this failure could be tip not smooth or rounded.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" corrections: d,f,g,h 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 evaluated.

Event Description

It was reported that the foley catheter with extra piece at tip noted on removal-pcn#(b)(6).Per sample received on 01nov2022, it was noted that the returned sample was pcn#(b)(6).

• Brand Name: BARDEX® ALL-SILICONE 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15826644
• MDR Text Key: 307608673
• Report Number: 1018233-2022-08835
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

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
• Device Operator: Health Professional
• Device Model Number: 165816
• Device Catalogue Number: 165816
• Device Lot Number: NGGN3696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/18/2022
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2022
• 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