MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® URETHRAL CATHETER; INTERMITTENT CATHETER

Catalog Number	120616
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that still missing 6 out of the intermittent catheter from the replacement.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.The potential root cause for this failure could be due to "lack of training packaging pattern not followed".The dhr review could not be performed without a lot number.A labeling review was not performed because labeling 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.The device was not returned.

• Brand Name: BARD® URETHRAL CATHETER
• Common Device Name: INTERMITTENT 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: 18787633
• Report Number: 1018233-2024-01004
• Device Sequence Number: 12845118
• Product Code: KOD
• UDI-Device Identifier: 00801741029974
• UDI-Public: (01)00801741029974
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2024

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: Lay User/Patient
• Device Catalogue Number: 120616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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