MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® VIRDEN RECTAL CATHETER

Catalog Number	0006590
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
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.Udi format updated with available product information per gudid.
Event or Problem Description
It was reported that everything in the box of rectal catheter was defective due to it missing a piece that keeps the balloon from inflating.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.Visual evaluation of the returned sample noted twelve unopened (without original packaging), rectal catheter.Visual inspection of the sample noted missing inflation cap on all of the catheters.This does not meet specification per which states wire preparation inflation wire process.Based on the results of the investigation, no actions can be taken at this time since a root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Labeling review is not required because labeling could not have prevented this issue.Correction- d, h.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 everything in the box of rectal catheter was defective due to it missing a piece that keeps the balloon from inflating.

• Brand Name: BARD® VIRDEN RECTAL CATHETER
• Common Device Name: RECTAL 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 20358284
• Report Number: 1018233-2024-06168
• Device Sequence Number: 8086369
• Product Code: KNT
• UDI-Device Identifier: 10801741122184
• UDI-Public: (01)10801741122184(11)231219(17)260713(10)MCHX2614
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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 Expiration Date: 07/13/2026
• Device Catalogue Number: 0006590
• Device Lot Number: MCHX2614
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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