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

Model Number	119112
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
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 on the next day after placement, the foley catheter fell out due to balloon rupture.On (b)(6) 2021, the catheter was placed during the breast surgery.In the midnight of the next day, the catheter fell out of the patient with no water inside the balloon when moving to the toilet in a wheelchair.
Event or Problem Description
It was reported that on the next day after placement, the foley catheter fell out due to balloon rupture.On (b)(6) , 2021, the catheter was placed during the breast surgery.In the midnight of the next day, the catheter fell out of the patient with no water inside the balloon when moving to the toilet in a wheelchair.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product was used for patient treatment.The product had not caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used three-way temp sensing silicone foley.Visual inspection of the sample noted 1 three-way foley temp sensing catheter inflated balloon with 5.5 ml of methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and allowed to rest with no observed leaks on the return sample.No missing pieces.With the syringe attached the balloon deflated in 1 min 13.60 sec passively with no issues.The reported failure could not be reproduced.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.As the reported event is unconfirmed a labeling review is not required.Correction: d, 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 inspected.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING FOLEY CATHETER
• Common Device Name: TEMPERATURE-SENSING 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12891778
• Report Number: 1018233-2021-07580
• Device Sequence Number: 1362311
• Product Code: EZL
• UDI-Device Identifier: 00801741046018
• UDI-Public: (01)00801741046018
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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 Expiration Date: 03/27/2025
• Device Model Number: 119112
• Device Catalogue Number: 119112
• Device Lot Number: NGEQ4214
• 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: 11/05/2021
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2020
• 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