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	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
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 foley tray kits had the betadine swabs in them which had a very small amount of betadine.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.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.No sample was returned for evaluation.A potential root cause for this failure could be due to "error of inspector".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review is not required because labeling could not have prevented the reported issue.Correction: h.H11: section a through f - the information provided by bard represents all of 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 bard.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the foley tray kits had the betadine swabs in them which had a very small amount of betadine.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12344780
• Report Number: 1018233-2021-05037
• Device Sequence Number: 14347708
• Product Code: EZC
• UDI-Device Identifier: 00801741074011
• UDI-Public: (01)00801741074011
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

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: 02/28/2023
• Device Model Number: A899916
• Device Catalogue Number: A899916
• Device Lot Number: NGFQ4338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2021
• 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