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

Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

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 customer received an incomplete set.Reportedly only the 10fr, 12fr and 24fr were received.

Event Description

It was reported that the customer received an incomplete set.Reportedly only the 10fr, 12fr and 24fr were received.

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
• Type of Device: HEYMAN COMPLETE KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8920613
• MDR Text Key: 155495865
• Report Number: 1018233-2019-04939
• Device Sequence Number: 1
• Product Code: FBW
• UDI-Device Identifier: 00801741075490
• UDI-Public: (01)00801741075490
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other,user facili
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1