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	12/29/2021
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.
Event or Problem Description
It was reported that the patient ordered 2 sets of followers and received only 1 each of 18fr and 20fr.There should be eight in each set and 1 each of 10fr-24fr.
Additional Manufacturer Narrative
The reported event was inconclusive because of poor sample condition.A bard heyman follower french size 18 and french size 20 were returned unopened in their individual packaging.The kit packaging was not returned.As the sample was returned opened from the kit, unable to determine if there were missing components.The product was not used on a patient.However the product is intended for treatment purposes.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 review of the labeling would not prevent the reported event.Corrections: d,h h11: section a through f - the information provided by bard 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 bard.
Event or Problem Description
It was reported that the patient ordered 2 sets of followers and received only 1 each of 18fr and 20fr.There should be eight in each set and 1 each of 10fr-24fr.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13286588
• Report Number: 1018233-2022-00071
• Device Sequence Number: 11863464
• Product Code: FBW
• UDI-Device Identifier: 00801741075490
• UDI-Public: (01)00801741075490
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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: 11/30/2025
• Device Model Number: 021100
• Device Catalogue Number: 021100
• Device Lot Number: MCFQ1788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2021
• 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