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

Model Number	166822
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician had asked if they could get different foley bulbs to replace those.Physician stated that they were not sure how much we knew about how they use them, but they did not use those catheter for bladder drainage.Stated that those they used it to insert into the cervix, blow the balloon up with fluid and manually dilate the cervix.The physician said that it was like trying to insert a cooked spaghetti noodle and inquired whether there were any that were stiffer.
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 is confirmed - user related based on the reported event.A potential root cause for this failure mode could be "user violation of standard practice".It was unknown whether the device had met specifications.The product was used for treatment purposes.The failure was caused by the misuse of the product.The device history record review could not be performed without a lot number.The instructions for use were found adequate and states the following: "caution: do not aspirate urine through drainage funnel wall.For urological use only.Recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 30cc balloon: use 35ml sterile water do not exceed recommended capacities.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol." the device was not returned.
Event or Problem Description
It was reported that the physician had asked if they could get different foley bulbs to replace those.Doctor said how much they knew about how they use them, but those they did not use for bladder drainage.Stated that those they use it to insert into the cervix below the balloon up with fluid and manually dilate the cervix.The physician that asked about them said it was like trying to insert a cooked spaghetti noodle and inquired whether there were any that were stiffer.

• Brand Name: BARDEX® 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15852633
• Report Number: 1018233-2022-08942
• Device Sequence Number: 15084434
• Product Code: GBM
• UDI-Device Identifier: 00801741029837
• UDI-Public: (01)00801741029837
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K760093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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: 166822
• Device Catalogue Number: 166822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 02/21/2023
• 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