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

Model Number	0165V18S
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
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.
Event or Problem Description
It was reported that the foley catheter balloon did not inflate.The customer stated that no urine returned, and the tip was broken.
Event or Problem Description
It was reported that the foley catheter balloon did not inflate.The customer stated that no urine returned, and the tip was broken.Per follow-up via phone on (b)(6) 2022, it was stated that the 21 products total were sent back by customer.No impact to the customer involved.
Additional Manufacturer Narrative
The reported event was inconclusive since sample condition was poor.It is unknown whether the device had met relevant specifications.The product was used for patient treatment or diagnosis.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be pinched lumen.Visual evaluation of the returned sample noted one opened (without original packaging), 20 unopened and 1 opened 2-way catheter from 2 box sets.Evaluation is on the opened catheter.Visual inspection noted that the balloon part of the catheter was broken into almost 2 separate parts but a small piece of silicone was keeping it together.Since the balloon was broken, it is unable to be further tested for flow rate of balloon inflation and deflation.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].Method for use: do not inflate the balloon in the urethra.[the urethra may be injured.].Do not pull the catheter hard.[the bladder/urethra may be injured.].Applicable patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.].[contraindications]: method for use: do not reuse.Do not resterilize.This device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.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.].Applicable patients with known allergy to silver coated catheter.¿.H11:section a through f - the information provided by bd 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 bd.

• Brand Name: BARDEX® SILICONE COATED 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: 14852649
• Report Number: 1018233-2022-04993
• Device Sequence Number: 11970156
• Product Code: EZC
• UDI-Device Identifier: 00801741039409
• UDI-Public: (01)00801741039409
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

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: 0165V18S
• Device Catalogue Number: 0165V18S
• Device Lot Number: NGGP0183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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