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

Catalog Number	A303316A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
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.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 the foley tray and the flush within the kit had a foreign product in it.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "no follow up to cleaning procedure in the production areas".The lot number is unknown; therefore, the device history record could not be reviewed.The labeling review was not performed because labeling could not have prevented the reported failure.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 the foley tray and the flush within the kit had a foreign product in it.
Event or Problem Description
It was reported that the foley tray and the flush within the kit had a foreign product in it.Per follow up via email on (b)(6) 2024, the sterile saline syringe in the surestep foley tray system was contaminated, looked like a piece of cardboard was in the syringe.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned photo sample noted one opened (without original packaging), sterile water syringe.Visual inspection of the photo sample noted unknown particles inside the sterile water syringe.This does not meet specification which states "loose foreign matter".The exact 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 ¿no follow up to cleaning procedure in the production areas¿.However, there was insufficient information to confirm this potential root cause.The reported event is addressed and the residual risk for this event is low.The device history record review could not be performed without a lot number.The instructions for use were found adequate and state the following: ¿surestep¿ foley tray system bardex® ic complete care® intended for use in the drainage and/or collection and/or measurement of urine.Generally done, drainage by inserting the catheter through the urethra and into the bladder.However, the drainage sometimes achieved through suprapubic or other placement of the catheter, such as through a nephrostomy.The patient has acute urinary retention or bladder outlet obstruction.Need for accurate measurements of urine output in critically ill patients.Use for select surgical procedures.To support the healing of open sacral or perineal wounds.The patient requires longer immobilization.To improve comfort during end-of-life care.This pre-connected closed system foley tray includes: bardex® i.C.Anti-infective foley catheter statlock® foley stabilization device antimicrobial control-fit¿ outlet device 350 ml urine meter bacteriostatic drainage tube bacteriostatic collection bag (2500 ml) 3 foam swabs povidone-lodine package peri-care set soap towels hand sanitizer warning: this product contains natural rubber latex, which can cause allergic reactions.Warning: do not use if you are allergic to iodine.For urological use only.Warning: do not use petroleum jelly-based ointments or lubricants on the catheter.They damage latex and can cause the balloon to burst.¿ 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 BARDEX® 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18640438
• Report Number: 1018233-2024-00461
• Device Sequence Number: 8067042
• Product Code: MJC
• UDI-Device Identifier: 00801741073793
• UDI-Public: (01)00801741073793
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2024

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: Lay User/Patient
• Device Catalogue Number: A303316A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 02/07/2024; 04/23/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 02/12/2024; 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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