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

Model Number	0134L18
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foley catheter fell out of the patient due to sterile water leakage.The catheter was inserted to the patient after operation and there was no problem during the pretest.However, when the patient returned to the ward, the catheter had fallen off.When the user checked the catheter again, water leaked from the drainage funnel.It was stated that the event happened six hours after placement.There was no rupture or tear in the balloon.Water leaked from the drainage eye into the inlet tube.No materials were possibly there in contact with the catheter and the catheter was inserted by hand.It was mentioned that health hazards to the patient were unknown.Per follow up information received via ibc on 22-nov-2022, stated that there were no health damages to the patient.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event is confirmed, manufacturing related.The used three-way foley catheter was returned without the original packaging.No visible defects were noted on the catheter.A potential root cause for this event could be, "operator error".No manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.A label/pack review is not required as a review of the label could not have prevented the reported event.H11: section a through f - the information provided by bd represents all 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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the foley catheter fell out of the patient due to sterile water leakage.The catheter was inserted to the patient after operation and there was no problem during the pretest.However, when the patient returned to the ward, the catheter had fallen off.When the user checked the catheter again, water leaked from the drainage funnel.It was stated that the event happened six hours after placement.There was no rupture or tear in the balloon.Water leaked from the drainage eye into the inlet tube.No materials were possibly there in contact with the catheter and the catheter was inserted by hand.It was mentioned that health hazards to the patient were unknown.Per follow up information received via ibc on 22nov2022, stated that there were no health damages to the patient.

• Brand Name: BARDEX®LUBRICATH® FOLEY CATHETER ALCOCK MODEL
• 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: 15869731
• Report Number: 1018233-2022-08977
• Device Sequence Number: 14766995
• Product Code: KOD
• UDI-Device Identifier: 00801741018756
• UDI-Public: (01)00801741018756
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K922431
• 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): 03/28/2023

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 Expiration Date: 07/31/2026
• Device Model Number: 0134L18
• Device Catalogue Number: 0134L18
• Device Lot Number: NGFZ1284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• 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