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

Model Number	A300316A
Medical Device Problem Code	Nonstandard Device (1420)
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.The device was not returned.
Event or Problem Description
It was reported that the povidone iodine swabsticks were not saturated enough.No medical intervention was reported.
Event or Problem Description
It was reported that the povidone iodine swabsticks were not saturated enough.No medical intervention was reported.
Additional Manufacturer Narrative
The device was not returned for evaluation.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: ¿this preconnected closed system foley tray contains: ¿ bardex® i.C.Anti-infective foley catheter¿ ¿ statlock® foley stabilization device ¿ anti-microbial control-fit outlet device ¿ anti-reflux chamber ¿ bacteriostatic drainage tube ¿ bacteriostatic collection bag (2000 ml) ¿ 3 foam swabs ¿ povidone-iodine packet¿¿ ¿ peri-care kit ¿ soap towelettes ¿ hand sanitizer".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.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® 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: 8200878
• Report Number: 1018233-2018-06221
• Device Sequence Number: 233835
• Product Code: MJC
• UDI-Device Identifier: 00801741073731
• UDI-Public: (01)00801741073731
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: A300316A
• Device Catalogue Number: A300316A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1