MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER TRAY

Model Number	899916
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
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.The device was not returned.
Event or Problem Description
It was reported that the nurses felt that they were having a difficult time in telling when the urine was done flowing in the straight catheter kit with the bag attached, compared to when the kit had a separate collection container.They confirmed having this problem, and usually they just manipulate the bag by lifting it up to see if it was still dripping or not.Nurses reported that with a 16fr tray containing a regular foley bag when they open the corners of the sterile field, the first sterile drape not fenestrated was placed above the gloves, so they could not remove it sterilely to use it to extend the sterile field.Additionally, there was significant concern with the size of the sterile field and not having room to pull out the tray to access the bag and catheter and aseptically lay the catheter into the lubricating gel.They were only using meter trays, and they had all surestep trays, so this was a smaller square tray with a bag that seemed a bit different.They felt it to be harder to manipulate sterilely.Per additional information received via email on 08dec2021, the customer reported that there wasn¿t an issue with the product draining but just a concern from nurses that they could not tell when the urine was done dripping into the bag, so they did not know when to remove the straight catheter.Also, they were concerned with the drape placement and the size of the sterile field compared to usability of the surestep tray.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "material does not meet specification".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.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 instructions for use were found adequate and state the following: "caution: this product contains natural rubber latex which may cause allergic reactions.For urological use only.Warning: on catheter do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon to burst." h11:section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that the nurses felt that they were having a difficult time in telling when the urine was done flowing in the straight catheter kit with the bag attached, compared to when the kit had a separate collection container.They confirmed having this problem, and usually they just manipulate the bag by lifting it up to see if it was still dripping or not.Nurses reported that with a 16fr tray containing a regular foley bag when they open the corners of the sterile field, the first sterile drape not fenestrated was placed above the gloves, so they could not remove it sterilely to use it to extend the sterile field.Additionally, there was significant concern with the size of the sterile field and not having room to pull out the tray to access the bag and catheter and aseptically lay the catheter into the lubricating gel.They were only using meter trays, and they had all surestep trays, so this was a smaller square tray with a bag that seemed a bit different.They felt it to be harder to manipulate sterilely.Per additional information received via email on (b)(6) 2021, the customer reported that there wasn't an issue with the product draining but just a concern from nurses that they could not tell when the urine was done dripping into the bag, so they did not know when to remove the straight catheter.Also, they were concerned with the drape placement and the size of the sterile field compared to usability of the surestep tray.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER TRAY
• Common Device Name: FOLEY CATHETER TRAY
• 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: 13114566
• Report Number: 1018233-2021-08528
• Device Sequence Number: 11611955
• Product Code: EZC
• UDI-Device Identifier: 00801741024818
• UDI-Public: (01)00801741024818
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

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: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Model Number: 899916
• Device Catalogue Number: 899916
• Device Lot Number: NGFU1394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown