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

Catalog Number	A319516AM
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	09/16/2024
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.This report references a us equivalent device.The us udi equivalent for this product number is used.H11: section a through f - 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.
Event or Problem Description
It was reported that doctor ordered to use a thermistor foley.Writer took a kit and inserted a new one.The kit had half-filled syringe of the sterile water supposedly to keep the foley in place.This was unusual for the kit; the balloon needed to have 10ml syringe.It was expected to the kit to have one.Writer kept the foley in place and used a 10ml sterile saline solution instead.Patient did not had apparent harm but felt inconvenient.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Root cause could not be identified.Although a root cause could not be definitively identified, a potential root cause for this type of failure could be " tip cover came off during shipping or in processing ".However, this potential root cause could not be confirmed.A labeling review was not performed because labeling could not have prevented the reported failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No actions can be taken at this time since a root cause was not identified.This report references a us equivalent device.The us udi equivalent for this product number is used.H11: section a through f - 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.
Event or Problem Description
It was reported that doctor ordered to use a thermistor foley.Writer took a kit and inserted a new one.The kit had half-filled syringe of the sterile water supposedly to keep the foley in place.This was unusual for the kit; the balloon needed to have 10ml syringe.It was expected to the kit to have one.Writer kept the foley in place and used a 10ml sterile saline solution instead.Patient did not had apparent harm but felt inconvenient.No medical intervention was reported.

• 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 20371795
• Report Number: 1018233-2024-06247
• Device Sequence Number: 3745353
• Product Code: MJC
• UDI-Device Identifier: 00801741073892
• UDI-Public: (01)00801741073892(11)240607(17)250731(10)NGJR0723
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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 Expiration Date: 07/31/2025
• Device Catalogue Number: A319516AM
• Device Lot Number: NGJR0723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2024
• 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