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

Model Number 021100

Device Problem Component Missing (2306)

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

Event Date 12/29/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event 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.

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 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
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13286588
• MDR Text Key: 285616405
• Report Number: 1018233-2022-00071
• Device Sequence Number: 1
• Product Code: FBW
• UDI-Device Identifier: 00801741075490
• UDI-Public: (01)00801741075490
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2021
• 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