MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP FOLEY TRAY SYSTEM LUBRI-SIL IC COMPLETE CARE; SURE STEP FOLEY TRAY SYSTEM

Model Number	A303414A
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 the foley catheter was missing the tray.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.Visual evaluation of the returned sample noted one opened (with original packaging), unused foley tray with label.It was noted that the sample port connector and the catheters were both missing.This does not meet the specification as "no missing components allowed".Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be incorrect operation.The lot number was unknown; therefore, the device history record could not be reviewed.Labeling review was not performed because labeling could not have prevented the reported failure.Correction: d10.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.
Event or Problem Description
It was reported that the foley catheter was missing the tray.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM LUBRI-SIL IC COMPLETE CARE
• Common Device Name: SURE STEP FOLEY TRAY SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10430999
• Report Number: 1018233-2020-05296
• Device Sequence Number: 17137529
• Product Code: MJC
• UDI-Device Identifier: 00801741073816
• UDI-Public: (01)00801741073816
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K984136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

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 Model Number: A303414A
• Device Catalogue Number: A303414A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1