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

Model Number	A899916
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
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.
Event or Problem Description
It was reported that the staff had foley tray (b)(6) for patient but was unable to use this tray because it has a metal clip and staff were new and did not know why their predecessors have been able to.Stated that staff was currently grabbing 154006 from other units and swapping that portion out.They have been pulling a drainage bag 154006 with a plastic drainage clip separately to insure there was no metal present in case the patient needs to go to magnetic resonance imaging (mri).They were currently breaking the closed system to add this bag since it did not have any metal.Stated that the customer could call for letter on mri safety bags with metal drainage clips since the mri instructions were not in the instructions for use (ifu).Customer preference: customer said their preference was to have the full kit (the (b)(6) but without a metal clip).
Event or Problem Description
It was reported that the staff had foley tray (a899916) for patient but was unable to use this tray because it has a metal clip and staff were new and did not know why their predecessors have been able to.Stated that staff was currently grabbing 154006 from other units and swapping that portion out.They have been pulling a drainage bag 154006 with a plastic drainage clip separately to insure there was no metal present in case the patient needs to go to magnetic resonance imaging (mri).They were currently breaking the closed system to add this bag since it did not have any metal.Stated that the customer could call for letter on mri safety bags with metal drainage clips since the mri instructions were not in the instructions for use (ifu).Customer preference: customer said their preference was to have the full kit (the a899916 but without a metal clip).
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "¿incorrect/ missing translation; missing instructions; vendor/printer error".It was unknown whether the device had met specifications.The product was used for treatment purposes.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.The instructions for use were found adequate and state the following: it states, "do not alter the statlock® device or components.Procedure must be performed by trained personnel with knowledge of anatomical landmarks, safe technique and potential complications." the device was not returned.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15680929
• Report Number: 1018233-2022-08158
• Device Sequence Number: 17729429
• Product Code: EZC
• UDI-Device Identifier: 00801741074011
• UDI-Public: (01)00801741074011
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2023

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: A899916
• Device Catalogue Number: A899916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 03/06/2023
• 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