MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® HEYMAN FOLLOWER

Model Number 021114

Device Problems Fitting Problem (2183); Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2023

Event Type  malfunction  

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.

Event 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).

Manufacturer Narrative

Per additional information received, bd has determined that this mdr event is not reportable.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 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) as 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.

• Brand Name: BARD® HEYMAN FOLLOWER
• Type of Device: HEYMAN FOLLOWER
• 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: 17134343
• MDR Text Key: 317564296
• Report Number: 1018233-2023-04346
• Device Sequence Number: 1
• Product Code: FBW
• UDI-Device Identifier: 00801741075520
• UDI-Public: (01)00801741075520
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 021114
• Device Catalogue Number: 021114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other