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

Catalog Number	A800365
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
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.Udi format updated with available product information per gudid as requested 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 patient was unable to void post-op, physican ordered foley catheter insertion.Nurse opened one foley catheter kit and catheter was missing (mw5157012).No extra foley catheter was available in department, so another kit was opened.Nurses discovered the covering of the catheter was torn opened (mw5157013).Nurses decided to open a third kit and again the covering over the catheter was torn (mw5157011).House supervisor was notified.
Event or Problem Description
It was reported that patient was unable to void post-op, physician ordered foley catheter insertion.Nurse opened one foley catheter kit and catheter was missing (mw5157012).No extra foley catheter was available in department, so another kit was opened.Nurses discovered the covering of the catheter was torn opened (mw5157013).Nurses decided to open a third kit and again the covering over the catheter was torn (mw5157011).House supervisor was notified.
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, based on the risk documentation review, a potential root cause for this type of failure could be "incorrect operation".However, there was insufficient information to confirm this potential root cause.The lot number is 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 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 patient was unable to void post-op, physician ordered foley catheter insertion.Nurse opened one foley catheter kit and catheter was missing (mw5157012).No extra foley catheter was available in department, so another kit was opened.Nurses discovered the covering of the catheter was torn opened (mw5157013).Nurses decided to open a third kit and again the covering over the catheter was torn (mw5157011).House supervisor was notified.
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, based on the risk documentation review, a potential root cause for this type of failure could be ¿incorrect operation.".However, there was insufficient information to confirm this potential root cause.The lot number is 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.Udi format updated with available product information per gudid as requested supplemental record submitted per request received on 08oct2024 to capture medwatch records referenced in the complaint details.Please note that mw5157013 is captured in mfr report #1018233-2024-05112, mw5157012 is captured in 1018233-2024-05113, and mw5157011 is captured in 1018233-2024-05124.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.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRICATH FOLEY
• 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: 20047998
• Report Number: 1018233-2024-05113
• Device Sequence Number: 20816729
• Product Code: EZC
• UDI-Device Identifier: 00801741073960
• UDI-Public: (01)00801741073960
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2024

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 Catalogue Number: A800365
• 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: 08/07/2024
• Supplement Date Received by Manufacturer: 08/28/2024; 10/08/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 08/30/2024; 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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