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

Model Number	802100
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 none of the insertion trays had water inside the syringes to blow up the balloon in order to anchor the foley catheter in place.
Event or Problem Description
It was reported that none of the insertion trays had water inside the syringes to blow up the balloon in order to anchor the foley catheter in place.
Additional Manufacturer Narrative
Per additional information received, there was no allegation against a bd device.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
• Common Device Name: URETHRAL TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10493804
• Report Number: 1018233-2020-05699
• Device Sequence Number: 14232780
• Product Code: KNX
• UDI-Device Identifier: 00801741051180
• UDI-Public: (01)00801741051180
• 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): 11/17/2020

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: Lay User/Patient
• Device Model Number: 802100
• Device Catalogue Number: 802100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1