MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® UNIVERSAL CATHETERIZATION TRAY; UNIVERSAL TRAY WITHOUT CATHETER

Model Number	792100
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.The device was not returned.
Event or Problem Description
It was reported that the tray did not contain the iodine swabsticks.
Event or Problem Description
It was reported that the tray did not contain the iodine swabsticks.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be " missing components / accessories and/or not according to proper assembly sequence.", a potential root cause for this failure could be "incorrect operation." the device history record was reviewed and found nothing that could have caused or contributed to the reported event.Currently supplied sterile component iodine pouch is unavailable from the supplier, lernapharm, inc.{montreal, quebéc, canada}.This waiver will remove iodine pouches from applicable trays/kits and include instructions to the end users.The instructions for use were found adequate and state the following: "contents: uro-prep¿ tray with: underpad, drape povidone-iodine solution 10cc syringe (prefilled with sterile water) to inflate 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.Specimen container and label walleted, powder-free gloves (2) 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.

• Brand Name: BARD® UNIVERSAL CATHETERIZATION TRAY
• Common Device Name: UNIVERSAL TRAY WITHOUT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8754356
• Report Number: 1018233-2019-03526
• Device Sequence Number: 11272693
• Product Code: OHR
• UDI-Device Identifier: 00801741029646
• UDI-Public: (01)00801741029646
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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): 07/25/2019

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: Health Professional
• Device Expiration Date: 01/30/2021
• Device Model Number: 792100
• Device Catalogue Number: 792100
• Device Lot Number: NGCT1850
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1