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	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the two foley kits were exactly the same.Stated that one foley kit had a sticker that contains latex, and one did not.Customer had different item numbers but were stocked in the same bin and used the same from a nursing perspective.Item#a300316a had a white sticker that stated it contains latex and item#a899916 had no sticker, and it did not indicate that it was latex free and customer did not know if it contained latex or not.Customer preference: item#a300316a had a white sticker that stated it contains latex and latex sticker was in lower righthand corner.The user would recommend a bright pink sticker or something a little more flashy.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product was not used for patient treatment.The product had not caused the reported failure.Visual evaluation of the returned sample noted one unopened (with original packaging), sure step foley tray system.Visual inspection of the sample noted the sure step foley tray system not labeled with the latex sticker.The photo sample provided shows material number "a300316a" with the white sticker which stated latex.Also noted that "a899916" not having the label does meet specification it does not request the latex label, so the reported catalog meets the requirements according to the applicable documents.The device history record and labeling review was not required since the reported failure was unconfirmed but was completed prior to the event being unconfirmed.The actual/suspected device was inspected.
Event or Problem Description
It was reported that the two foley kits were exactly the same.Stated that one foley kit had a sticker that contains latex, and one did not.Customer had different item numbers but were stocked in the same bin and used the same from a nursing perspective.Item#a300316a had a white sticker that stated it contains latex and item#a899916 had no sticker, and it did not indicate that it was latex free and customer did not know if it contained latex or not.Customer preference: item#a300316a had a white sticker that stated it contains latex and latex sticker was in lower right hand corner.The user would recommend a bright pink sticker or something a little more flashy.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15047684
• Report Number: 1018233-2022-05582
• Device Sequence Number: 4773105
• Product Code: EZC
• UDI-Device Identifier: 00801741074011
• UDI-Public: (01)00801741074011
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/07/2022

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: 01/31/2023
• Device Model Number: A899916
• Device Catalogue Number: A899916
• Device Lot Number: NGEV1569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2020
• 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