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

Model Number	021100
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It was unknown whether the device had met relevant specifications.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be, "operator error".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required as the reported event is unlikely to be caused by the user.
Event or Problem Description
It was reported that there was missing product within the packaging.Customer only received one set of 10 french followers in their shipment when it should include various sizes up to 24 french.

• Brand Name: BARD® HEYMAN FOLLOWER
• Common Device Name: 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15051944
• Report Number: 1018233-2022-05590
• Device Sequence Number: 4821724
• Product Code: FBW
• UDI-Device Identifier: 00801741075490
• UDI-Public: (01)00801741075490
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2022

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: 07/31/2026
• Device Model Number: 021100
• Device Catalogue Number: 021100
• Device Lot Number: MCFY0024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• 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