MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD HEYMAN FOLLOWERS STRAIGHT TIP COMPLETE SET 10-24 FR., STERILE; HEYMAN COMPLETE KIT

Model Number	021100
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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 customer received an incomplete set.Reportedly only the 10fr, 12fr and 24fr were received.
Event or Problem Description
It was reported that the customer received an incomplete set.Reportedly only the 10fr, 12fr and 24fr were received.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The reported event was unrelated to labeling.Therefore, a labeling review was not required.

• Brand Name: BARD HEYMAN FOLLOWERS STRAIGHT TIP COMPLETE SET 10-24 FR., STERILE
• Common Device Name: HEYMAN COMPLETE KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8920613
• Report Number: 1018233-2019-04939
• Device Sequence Number: 11249847
• Product Code: FBW
• UDI-Device Identifier: 00801741075490
• UDI-Public: (01)00801741075490
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other,user facili
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019

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: 09/30/2023
• Device Model Number: 021100
• Device Catalogue Number: 021100
• Device Lot Number: MCDS4846
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1