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

Model Number	772514
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.
Event or Problem Description
It was reported that the iodine swabs in the urethral catheterization trays were missing.
Event or Problem Description
It was reported that the iodine swabs in the urethral catheterization trays were missing.
Additional Manufacturer Narrative
The reported event was unconfirmed, as the product could not fail to meet the specifications.The device would not fail to meet the relevant specifications.The product used for treatment purposes.The product was related to the reported failure.A potential root cause for this failure mode could be due to ¿incorrect operation.¿ neither a dhr review nor manufacturing review were completed because the reported event was unconfirmed.The instructions for use were found adequate and state the following: "this product does not contain povidone-iodine as indicated on the primary packaging.Please obtain appropriate antiseptic or sterile solution to perform peri urethral cleaning prior to catheter insertion using established aseptic technique." 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 URETHRAL CATHETERIZATION TRAY WITH PLASTIC CATHETER
• Common Device Name: URETHRAL CATHETERIZATION TRAYS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10137135
• Report Number: 1018233-2020-03692
• Device Sequence Number: 16667700
• Product Code: KOD
• UDI-Device Identifier: 00801741030444
• UDI-Public: (01)00801741030444
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

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: 01/31/2021
• Device Model Number: 772514
• Device Catalogue Number: 772514
• Device Lot Number: NGCR0120
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1