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

Model Number	087016
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
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.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.
Event or Problem Description
It was reported that ureteral catheters had a hair in the sterile package.Per follow-up via email on 01jun2023, the product never touched the sterile field, so no harm or potential harm came to the patient.
Event or Problem Description
It was reported that ureteral catheters had a hair in the sterile package.Per follow-up via email on 01jun2023, the product never touched the sterile field, so no harm or potential harm came to the patient.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.Visual evaluation of the returned sample noted one opened (with original packaging) and, unused bardex edelman catheter.Visual inspection of the sample noted one long strand of hair inside of the packaging.This does not meet specification per "loose foreign matter, engraved and spots >1/32¿ is not allowed".A potential root cause for this failure mode could be ¿no follow up to good manufacturing practices".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labelling could not have prevented the reported failure.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.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.1 sample were confirmed to exhibit the reported failure.The device had not met specifications.Visual evaluation of the returned sample noted one opened (with original packaging) and, unused bardex edelman catheter.Visual inspection of the sample noted one long strand of hair inside of the packaging.This does not meet specification which states that loose foreign matter, engraved and spots greater-than 1/32 is not allowed.The exact root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be defective/ contaminated components from the supplier.However, there was insufficient information to confirm this potential root cause.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.A labeling review was not performed because labelling could not have prevented the reported failure.Udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that ureteral catheters had a hair in the sterile package.Per follow-up via email on 01jun2023, the product never touched the sterile field, so no harm or potential harm came to the patient.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER EDELMAN 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: 17143860
• Report Number: 1018233-2023-04410
• Device Sequence Number: 19299928
• Product Code: EZC
• UDI-Device Identifier: 00801741039232
• UDI-Public: (01)00801741039232(11)211211(17)240131(10)NGFY2648
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• 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,Followup
• Report Date (Section B): 08/15/2024

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: 01/31/2024
• Device Model Number: 087016
• Device Catalogue Number: 087016
• Device Lot Number: NGFY2648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 10/11/2023; 08/15/2024
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 10/12/2023; 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2021
• 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