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

Model Number	A303416A
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that saline syringe which supposed to contain saline was empty and the plunger was missing.It was also stated that there was no lubricant in the lubricant syringe.
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 saline syringe which supposed to contain saline was empty and the plunger was missing.It was also stated that there was no lubricant in the lubricant syringe.
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¿.It is unknown whether the device had met relevant specifications.The product was not used on the patient.It was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.Labeling review is not required because a review of the label could not have prevented this issue.The information provided by bd represents all 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 LUBRI-SIL® IC COMPLETE CARE®
• Common Device Name: 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: 15335672
• Report Number: 1018233-2022-06818
• Device Sequence Number: 20452532
• Product Code: EZL
• UDI-Device Identifier: 00801741073823
• UDI-Public: (01)00801741073823
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

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: A303416A
• Device Catalogue Number: A303416A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 11/18/2022
• 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