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

Model Number	A300416A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 information provided by bard 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 bard.
Event or Problem Description
It was reported that there was no catheter in the tray.The tray was allegedly used up to the point of insertion, then the hospital staff had to start over because there was no catheter to insert.No impact to the patient.
Additional Manufacturer Narrative
A photo sample was received and evaluated.The reported issue was confirmed as a manufacturing related issue.Upon review of the photo, it was noted that the catheter was not assembled to the tube,, as there was no catheter in the tray.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: "this preconnected closed system foley tray contains: lubri-sil® i.C.Anti-microbial foley catheter." the information provided by bard 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 bard.
Event or Problem Description
It was reported that upon attempting to utilize the catheter tray, it was noted that the catheter was missing from the tray.There was no reported patient impact to the patient.
Additional Manufacturer Narrative
The reported issue was confirmed, after visual evaluation.During visual inspection, it was noted that the catheter connector and catheter were not connected to the drainage tubing and were missing in the tray.The pvc tube did not have evidences of solvent.The catheter was not put in the pvc tube.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: "this preconnected closed system foley tray contains: lubri-sil i.C.Anti-microbial foley catheter.".
Event or Problem Description
It was reported that upon attempting to utilize the catheter tray, it was noted that the catheter was missing from the tray.There was no reported patient impact to the patient.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®
• Common Device Name: SURESTEP FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6578544
• Report Number: 1018233-2017-02517
• Device Sequence Number: 18983183
• Product Code: EZL
• UDI-Device Identifier: 00801741073762
• UDI-Public: (01)00801741073762
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2017

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: A300416A
• Device Catalogue Number: A300416A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: Not provided; 09/08/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 06/15/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1