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

Model Number	021300
Medical Device Problem Code	Inadequate Instructions for Healthcare Professional (1319)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 a heyman follower labeled with ref # (b)(4) was shipped inside of a case labeled ref # (b)(4).There was no patient involvement.
Additional Manufacturer Narrative
The reported event was unconfirmed since the sample met specifications.Per evaluation, each of the following french size from 10-24 were included in the container which include 021310.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿1.Bard® heyman¿ followers are intended to be used with bardex® councill catheters and bard® heyman¿ filiform catheters.All individual devices are disposable and sold sterile.2.The filiform catheter comes packaged with a disposable stylet to use for insertion.Insert the bard® heyman¿ filiform catheter with stylet in place.The filiform catheter may be placed by inserting through a cystoscope under direct vision.Direct view catheter placement will decrease the number of difficult and possible false passages.3.There is a 3 centimeter orientation marking on the filiform catheter at 30 centimeters from the distal end to assist with placing the filiform catheter in the bladder.Placement of the filiform catheter in the bladder can be determined by removing the stylet and observing urine or aspirating urine with a syringe.If added confirmation is necessary, a radio graph can be taken after injecting radiopaque dye into the filiform catheter.When the filiform catheter has been properly placed, the stylet should be discarded.4.Starting with the smaller sizes, slip the bard® heyman¿ followers (straight or coude) over the filiform catheter.Increase the follower size until the desired dilation is accomplished.5.Slip a bardex® councill catheter over the filiform catheter and when it is in place, inflate balloon.Remove the filiform catheter.If, at a later time, the councill catheter is to be replaced, insert a new filiform catheter prior to removing the councill catheter.The filiform catheter will then guide the new councill catheter into place.After use, this product may be potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Warning: because the filiform catheter may advance with the passage of the followers, a length of the filiform catheter should always appear beyond the proximal end of the follower, otherwise the filiform catheter may be left in the urethra when the follower is withdrawn.Bard".
Event or Problem Description
It was reported that a heyman follower labeled with ref # 021310 was shipped inside of a case labeled ref # 021300.There was no patient involvement.

• Brand Name: BARD HEYMAN FOLLOWERS COUDE TIP, COMPLETE SET 10-24 FR., STERILE
• Common Device Name: HEYMAN FOLLOWER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8231523
• Report Number: 1018233-2019-00185
• Device Sequence Number: 216783
• Product Code: FBW
• UDI-Device Identifier: 00801741075582
• UDI-Public: (01)00801741075582
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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: 01/31/2023
• Device Model Number: 021300
• Device Catalogue Number: 021300
• Device Lot Number: MCCU1530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 01/09/2019
• Supplement Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1