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

Model Number	0166L20
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Event or Problem Description
It was reported that the catheter balloon would not inflate.
Additional Manufacturer Narrative
The reported issue was unconfirmed.The device was returned and the exterior of the sample was visually inspected, and did not find any evidence of a failure that would support the reported event.The functional evaluation found that the catheter could be inflated without difficulty.The catheter was dissected and found no conditions that would contribute to the reported problem.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿contraindications method for use: do not reuse.Do not resterilize.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.] 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.]" (b)(4).
Event or Problem Description
It was reported that the catheter balloon did not inflate.
Additional Manufacturer Narrative
The reported issue was unconfirmed.The device was returned and visually inspected the exterior of the sample, and did not find any evidence of a failure that would support the reported event.Evaluation found catheter can be inflated without difficulty.Dissected the catheter and found no conditions that would contribute to the reported problem.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿contraindications method for use: do not reuse.Do not resterilize.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.] 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.]" (b)(4).Correction: manufacturer name, city and state and mfr site.
Event or Problem Description
It was reported that the catheter balloon did not inflate.

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6711080
• Report Number: 1018233-2017-03723
• Device Sequence Number: 16351642
• Product Code: MJC
• UDI-Device Identifier: 00801741017605
• UDI-Public: (01)00801741017605
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2017

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: Lay User/Patient
• Device Expiration Date: 02/28/2020
• Device Model Number: 0166L20
• Device Catalogue Number: 0166SI20
• Device Lot Number: 5ED7034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 08/05/2017; 12/11/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 08/25/2017; 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1