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

Model Number	782102
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.
Event or Problem Description
It was reported that one case (qty: 20) did not include the povidone-iodine solution.This was noted prior to use.
Additional Manufacturer Narrative
The reported event could not be confirmed.It was unknown whether the device had met specifications due to no sample was returned for evaluation.The product was used for treatment purposes.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 fi eld.2.Place underpad beneath patient, plastic side down.3.Put on cuffed gloves.4.Position drape on patient.5.Remove top tray.6.Open lubricant.Lubricate catheter.7.Pour cleansing solution onto prep balls.8.Prep patient with saturated prep balls.9.Proceed with catheterization in usual manner.10.If specimen is required, fi ll sterile container from catheter.11.Top tray may be placed on basin to help prevent spillage.12.If urine is placed in specimen jar: a.Secure cap.B.Label specimen jar.C.Send specimen to laboratory." 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 one case (qty: 20) did not include the povidone-iodine solution.This was noted prior to use.

• Brand Name: BARD® FOLEY CATHETERIZATION TRAY URO-PREP¿ TRAY
• Common Device Name: FOLEY CATHETER TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9310592
• Report Number: 1018233-2019-07248
• Device Sequence Number: 2335210
• Product Code: KNX
• UDI-Device Identifier: 00801741029639
• UDI-Public: (01)00801741029639
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/15/2019

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: 782102
• Device Catalogue Number: 782102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1