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

Model Number	01267520
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a crack on the foley catheter tip upon opening the package.The device was not used.
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 there was a crack on the foley catheter tip upon opening the package.The device was not used.
Additional Manufacturer Narrative
The reported event is confirmed, manufacturing related.Photo samples were submitted which showed what appeared to be a cut at the tip of the catheter.The 3 way foley catheter was returned without the original packaging.The cut at the tip of the catheter appear to have been made by a sharp object and a small blue fragment could be seen within the cut on the catheter.The catheter was viewed under a microscope at 15x and 20x magnifications and the blue fragment was seen more clearly and confirmed to be a piece of the blue sleeve that encloses the catheter.Based on this information this event will be confirmed manufacturing related due to bagger machine cut.This is out of specifications which states, "catheters damaged by hot knife are to be scrapped.This includes burned catheters, cut catheters or cracked caps." unable to identify the specific cause of the reported event, however, based on the risk document a potential root cause for this event could be, "operator error".As no patient involvement was reported the device was not used on a patient, however, is intended for treatment purposes.The device history record was reviewed and found nothing 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.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER CREEVY MODEL
• Common Device Name: FOLEY CATHETER (LATEX)
• 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: 15224139
• Report Number: 1018233-2022-06358
• Device Sequence Number: 5566537
• Product Code: EZC
• UDI-Device Identifier: 00801741018800
• UDI-Public: (01)00801741018800
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910195
• 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): 01/20/2023

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: 09/30/2024
• Device Model Number: 01267520
• Device Catalogue Number: 01267520
• Device Lot Number: NGEY0501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2021
• 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