MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® FOLEY CATHETERIZATION TRAY URO-PREP¿ TRAY; SURESTEP FOLEY KIT

Model Number	782100
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); 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.The device was not returned.
Event or Problem Description
It was reported that the iodine was missing from the kit.No medical intervention was required.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿contents: uro-prep¿ tray with: underpad, drape povidone-iodine solution npn 02076144 10cc syringe (prefilled with sterile water) to inflate foley catheter only.Sterile: contents of inner wrap are sterile unless package is opened or damaged.Directions for use on reverse side.Single use only.Do not resterilize.For urological use only.Latex-free, powder-free gloves(2) specimen container and label lubricant packet, forceps, prep balls (5) graduated collection container" 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the iodine was missing from the kit.No medical intervention was required.

• Brand Name: BARD® FOLEY CATHETERIZATION TRAY URO-PREP¿ TRAY
• Common Device Name: SURESTEP FOLEY KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9194251
• Report Number: 1018233-2019-06504
• Device Sequence Number: 14225602
• Product Code: KNX
• UDI-Device Identifier: 00801741029622
• UDI-Public: (01)00801741029622
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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: Lay User/Patient
• Device Model Number: 782100
• Device Catalogue Number: 782100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1