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

Model Number	0166SI24
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
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 balloon with 20cc water was not making a round balloon, the patient is using the catheter as a feeding tube per the doctor¿s instructions,per troubleshooting the mss response the method of inflating the balloon.Follow up 1 via phone on 25sep2020, the customer noted that the balloon burst while in use due to the stomach acid.No missing pieces were observed.
Event or Problem Description
It was reported that the balloon with 20 cc water was not making a round balloon, the patient was using the catheter as a feeding tube per the doctor¿s instructions.Per troubleshooting the mss responded to the method of inflating the balloon.Per follow up 1 via phone on (b)(6) 2020, the customer noted that the balloon burst while in use due to the stomach acid.No missing pieces were observed.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was initially reported in error as per the investigation the event is related to user, since there is no device malfunction.Hence this event is not reportable.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 I.C. FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10703606
• Report Number: 1018233-2020-20220
• Device Sequence Number: 3025136
• Product Code: MJC
• UDI-Device Identifier: 00801741016882
• UDI-Public: (01)00801741016882
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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 Model Number: 0166SI24
• Device Catalogue Number: 0166SI24-BARD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other