MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD ALL PURPOSE URETHRAL CATHETER

Model Number	0094100
Medical Device Problem Code	Inadequate Instructions for Healthcare Professional (1319)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2020
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.The device was not returned.
Event or Problem Description
It was reported that the (b)(4) - (b)(6) 10fr was shipped instead of ref (b)(4).Identified in stock and prevented from using.
Additional Manufacturer Narrative
Per additional information received the customer ordered a wrong product, hence bd has determined that this mdr event is not reportable.H11:section a through f - the information provided by bd represents all of 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 device was not returned.
Event or Problem Description
It was reported that the 9094100 - brd9094100 - cath robinson 10fr was shipped instead of ref (b)(4).Identified in stock and prevented from using.

• Brand Name: BARD ALL PURPOSE URETHRAL CATHETER
• Common Device Name: URETHRAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11044442
• Report Number: 1018233-2020-21819
• Device Sequence Number: 19148568
• Product Code: KOD
• UDI-Device Identifier: 00801741034008
• UDI-Public: (01)00801741034008
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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 Model Number: 0094100
• Device Catalogue Number: 94100
• Device Lot Number: MCDU2628
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other