MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 WOVEN FILIFORM STRAIGHT TIP

Model Number	021906
Medical Device Problem Codes	Fitting Problem (2183); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer had bard followers and filiforms but the tips were not connecting.(pcn 021114 , pcn 021112 , pcn 021116 , pcn 021118 , pcn 021120 , pcn 021122 , pcn 021124 , pcn 021316 , pcn 021100, pcn 021905 , pcn 021906 , pcn 022105).
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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that customer had bard followers and filiforms but the tips were not connecting.(pcn 021114 , pcn 021112 , pcn 021116 , pcn 021118 , pcn 021120 , pcn 021122 , pcn 021124 , pcn 021316 , pcn 021100, pcn 021905 , pcn 021906 , pcn 022105).Per additional information received via email on 06jul2023, it was reported that customer thought there might have been some confusion with this.There was not issue with the product itself and they had mismatched followers and filiform on hand which caused an issue, on their end they figured out the issue and just had the wrong products.
Additional Manufacturer Narrative
Per additional information received, bd has determined that this mdr event is not reportable.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.

• Brand Name: WOVEN FILIFORM STRAIGHT TIP
• Common Device Name: WOVEN FILIFORM STRAIGHT TIP
• 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: 17134346
• Report Number: 1018233-2023-04347
• Device Sequence Number: 6448774
• Product Code: FBW
• UDI-Device Identifier: 00801741073106
• UDI-Public: (01)00801741073106
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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 Model Number: 021906
• Device Catalogue Number: 021906
• 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: 05/24/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 10/31/2023
• 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