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

Model Number	01267520
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	04/06/2023
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 the water injected into the balloon has high resistance due to a dust found.Per additional information via email from ibc on 14apr2023,water injected into the balloon has high resistance ('dust was found').
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product was not used for patient treatment.The product had not caused the reported failure.Visual evaluation of the returned sample noted one opened (with original packaging), foley catheter.Visual inspection of the sample noted the balloon inflated concentrically with 75cc di water using a slip tip syringe and deflated passively with no issues.No foreign material was noted on or within the catheter.No root cause could be found because the reported event was unconfirmed.Dhr is not required since the reported failure was unconfirmed.As the reported event is unconfirmed a labeling review is not required.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.The actual/suspected device was inspected.
Event or Problem Description
It was reported that the water injected into the balloon has high resistance due to a dust found.Per additional information via email from ibc on 14apr2023,water injected into the balloon has high resistance ('dust was found' - this part is redundant).

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER CREEVY 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: 16831035
• Report Number: 1018233-2023-02968
• Device Sequence Number: 16621123
• Product Code: EZC
• UDI-Device Identifier: 00801741018800
• UDI-Public: (01)00801741018800
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K910195
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023

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: 03/31/2025
• Device Model Number: 01267520
• Device Catalogue Number: 1267520
• Device Lot Number: NGGW4067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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