MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® SILASTIC® FOLEY CATHETER

Catalog Number	33616
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter's phone number: (b)(6).The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Udi format updated with available product information per gudid.H11: sections 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 1 piece of foley catheter with empty packaging code 33616 lot ngjw0884 was detected.When tracking, there was an entry of 29may2025 of the mentioned lot, entry voucher 5001015684, order (b)(4).Therefore, folio rip-144-2025 was generated and 1 piece was blocked in the set.Additional information received on 25 sep 2025.The defect was detected on (b)(6) 2025.The sample is available for return and analysis.The packaging has no leakage.
Event or Problem Description
It was reported that 1 piece of foley catheter with empty packaging code 33616 lot ngjw0884 was detected.When tracking, there was an entry of 29may2025 of the mentioned lot, entry voucher 5001015684, order 4500059406.Therefore, folio rip-144-2025 was generated and 1 piece was blocked in the set.Per additional information received via ibc on 25sep2025, stated that packaging had no leakage.And defect was detected on 23sep2025.Additional information received on 25 sep 2025.The defect was detected on 23.09.2025.The sample is available for return and analysis.The packaging has no leakage.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned two-photo sample noted one (with original packaging), foley catheter.Visual inspection of the first photo sample noted the front side of the product packaging.The second photo shows the backside of the product packaging with no product inside the packaging.A labeling review is not required because labeling could not have prevented the reported issue.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Correction: d, e, h.Udi format updated with available product information per gudid.H11: sections 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.

• Brand Name: BARD® SILASTIC® FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23222167
• Report Number: 1018233-2025-08839
• Device Sequence Number: 9459271
• Product Code: EZL
• UDI-Device Identifier: 00801741020063
• UDI-Public: (01)00801741020063(11)241003(17)280930(10)NGJW0884
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K951103
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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 Catalogue Number: 33616
• Device Lot Number: NGJW0884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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