MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® UROLOGIST'S TRAY; DILATION TRAY

Model Number	123400
Medical Device Problem Code	Misassembled (1398)
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 upon opening the package the wire was poking out of catheter.
Additional Manufacturer Narrative
The reported event was confirmed.A filiform catheter was returned.The stylet was sticking out of the catheter.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.Insert the bard® heyman¿ filiform catheter with stylet in place.The catheter may be placed by inserting through a cystoscope under direct vision.Direct view catheter placement should decrease the number of difficult and possible false passages.2.Placement of the filiform catheter in the bladder can be confirmed by removing the stylet and observing urine flow or aspirating urine with a syringe.If added confirmation is necessary, a radiograph can be taken after injecting radiopaque dye into the filiform catheter.When the filiform catheter has been properly placed, the stylet should be discarded.3.Starting with the smaller sizes, slip the bard® heyman¿ followers (straight or coudé) over the filiform catheter.Increase the follower size until the desired dilation is accomplished.4.Slip a bardex® councill catheter over the filiform and, when in place, inflate balloon.Remove the filiform.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 will then guide the new councill catheter into place.5.For more difficult catheter insertions, lubricate the bard® heyman¿ metal stylet with the provided catheter lubricant and insert it into the councill catheter.The stylet serves to guide the councill catheter over the filiform.6.There is a 3 centimeter orientation marker on the filiform catheter at 30 centimeters from the distal (closed) end.When this marker is positioned at the external meatal orifice, this usually signifies that the distal (closed) end is in the bladder.7.The filiform catheter is soft and pliable after the stylet is removed.In case the filiform is advanced, it will safely curl up in the bladder.8.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Warning: because this 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 urethral instrument; otherwise, the filiform catheter may be left in the urethra when the instrument is withdrawn.".
Event or Problem Description
It was reported that upon opening the package the wire was poking out of catheter.

• Brand Name: BARD® UROLOGIST'S TRAY
• Common Device Name: DILATION TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8307078
• Report Number: 1018233-2019-00606
• Device Sequence Number: 53388
• Product Code: KOE
• UDI-Device Identifier: 00801741000294
• UDI-Public: (01)00801741000294
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/06/2019

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: 03/31/2021
• Device Model Number: 123400
• Device Catalogue Number: 123400
• Device Lot Number: NGCT2056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1