MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URETHRAL CATHETERIZATION TRAY WITH VINYL CATHETER

Model Number	772417
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 wrong product was in the package.The customer was missing iodine.Per additional information received 26nov2019, the customer confirmed that there was not an incorrect device in the package, the iodine was missing from the package.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿missing components/ accessories and/or not according to proper assembly sequence¿ with a potential root cause of "incorrect operation".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: "directions for use: visually inspect the product for any imperfections or surface deterioration prior to use.1.Open csr wrap to form sterile field.2.Place underpad beneath patient, plastic side down.3.Put on cuffed gloves.4.Position drape on patient.5.Remove top tray.6.Lubricate catheter.7.Prep patient with povidone-iodine swabsticks.8.Proceed with catheterization in usual manner.9.If specimen is required, fill sterile container from catheter.10.Top tray may be placed on basin to help prevent spillage.11.If urine is placed in specimen jar: a.Secure cap.B.Label specimen jar.C.Send specimen to laboratory.".
Event or Problem Description
It was reported that the wrong product was in the package.The customer was missing iodine.Per additional information received (b)(6) 2019, the customer confirmed that there was not an incorrect device in the package, the iodine was missing from the package.

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY WITH VINYL CATHETER
• Common Device Name: TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9481228
• Report Number: 1018233-2019-08019
• Device Sequence Number: 11460871
• Product Code: KOD
• UDI-Device Identifier: 00801741030437
• UDI-Public: (01)00801741030437
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2019

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 Model Number: 772417
• Device Catalogue Number: 772417
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 12/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1