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

Model Number	A902916
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon opening the foley kit, the syringe for balloon inflation have only 4 ml of water instead of 10 ml of water so that the syringe was removed from the kit and a new sterile syringe and water were put onto the sterile field to inflate the balloon after foley catheter insertion.
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 upon opening the foley kit, the syringe for balloon inflation have only 4 ml of water instead of 10 ml of water so that the syringe was removed from the kit and a new sterile syringe and water were put onto the sterile field to inflate the balloon after foley catheter insertion.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "tip cover came off during shipping or in processing".The lot number was unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because labeling could not have prevented the reported failure.H11: section a through f - 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.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: SURESTEP FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14459539
• Report Number: 1018233-2022-03957
• Device Sequence Number: 14578771
• Product Code: EZC
• UDI-Device Identifier: 00801741074073
• UDI-Public: (01)00801741074073
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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: A902916
• Device Catalogue Number: A902916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 07/30/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown