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

Model Number	909116M
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 forceps and the iodine swabsticks were missing from the tray.Remaining products were used with no impact.
Event or Problem Description
It was reported that the forceps and the iodine swabsticks were missing from the tray.Remaining products were used with no impact.
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 instructions for use were found adequate and state the following: contents: bardex® lubricath® 400-series temperature-sensing foley catheter urine meter (350ml capacity) attached to drainage bag (2500ml approx.Vol.), bard® ez-lok® sampling port, attached sheeting clips (2).Control-fittm outlet device.Tamper-evident seal.Uro-preptm tray with: catheter lubricating jelly syringe (10cc), latex-free, powder-free gloves (2), underpad (waterproof), forceps/drape/prep balls, povidone-iodine solution, specimen container, cap and label, 10cc syringe (prefilled with sterile water), to inflate catheter only.
Event or Problem Description
It was reported that the forceps and the iodine swabsticks were missing from the tray.Remaining products were used with no impact.
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 instructions for use were found adequate and state the following: "contents: ** bardex® lubricath® 400-series temperature-sensing foley catheter ** urine meter (350ml capacity) attached to drainage bag (2500ml approx.Vol.) bard® ez-lok® sampling port attached sheeting clips (2) control-fittm outlet device ¿ tamper-evident seal ¿ uro-preptm tray with: catheter lubricating jelly syringe (10cc) latex-free, powder-free gloves (2) underpad (waterproof) forceps/drape/prep balls povidone-iodine solution specimen container, cap and label 10cc syringe (prefilled with sterile water) to inflate catheter only sterile: contents of inner wrap are sterile unless package has been opened or damaged.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Bardex® lubricath® temperature-sensing foley catheter - 5cc balloon 16 fr.Single use only.Do not resterilize.For urological use only.".

• Brand Name: BARDEX® LUBRICATH® TEMPERATURE-SENSING URINE METER FOLEY TRAY
• Common Device Name: TEMPERATURE SENSING FOLEY CATHETER TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8337389
• Report Number: 1018233-2019-00775
• Device Sequence Number: 11096001
• Product Code: EZC
• UDI-Device Identifier: 00801741029158
• UDI-Public: (01)00801741029158
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2019

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: 06/30/2021
• Device Model Number: 909116M
• Device Catalogue Number: 909116M
• Device Lot Number: NGCV2148
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 02/22/2019; 05/20/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 03/15/2019; 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1