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

Catalog Number	A800061
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	08/28/2023
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 syringe from the surestep foley tray had hair on the cap.Fortunately, they noticed the hair before using the syringe on a patient's sterile procedure.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.1 sample were confirmed to exhibit the reported failure.The device had not met specifications.The product caused the reported failure.Visual evaluation of the returned photo sample noted one opened (with original packaging), lubcath foley tray.Visual inspection of the photo sample noted a strand of hair underneath the syringe cap.This does not meet specification per inspection procedure which states that "no hair on the product is allowed".A potential root cause for this failure mode could be "defective components from supplier / contamination".The device history record review could not be performed without a lot number.The instructions for use were found adequate and state the following: ¿intended for use in the drainage and/or collection and/or measurement of urine.Does this patient meet the cdc guidelines for indwelling urethral catheter for use? ¿ patient has acute urinary retention or bladder outlet obstruction ¿ need for accurate urine output measurements ¿ use for selected surgical procedures ¿ to assist in healing of open sacral or perineal wounds ¿ patient requires prolonged immobilization ¿ to improve comfort for end of life care caution: this product contains natural rubber latex which may cause allergic reactions.Warning: do not use if allergic to iodine.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petroleum base.They will damage latex and may cause balloon to burst.¿ 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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the syringe from the surestep foley tray had hair on the cap.Fortunately, they noticed the hair before using the syringe on a patient's sterile procedure.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRICATH® FOLEY CATHETER TRAY
• 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: 17763785
• Report Number: 1018233-2023-06831
• Device Sequence Number: 7094344
• Product Code: EZC
• UDI-Device Identifier: 00801741104848
• UDI-Public: (01)00801741104848
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 02/05/2024

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: A800061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 02/08/2024
• 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