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

Model Number	A899914
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Use of Device Problem (1670)
Health Effect - Clinical Codes	Reaction (2414); Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was confirmed as user-related.Visual inspection noted two photo samples were received.The event inferred that once the products reached the hospital, the nurses relabeled the products with their own label to help identify latex and non-latex products.Visual evaluation noted one of the photo samples had one product with the "non-nrl" label on it properly relabeled with a "non-latex" sticker.The photo also showed two samples that did not have the "non-nrl" label with the proper "this product contains latex" stickers.The other photo sample showed a foley tray without the "non-nrl" label improperly relabeled with a "non-latex" sticker.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "caution this product contains natural rubber latex which may cause allergic reactions.".
Event or Problem Description
It was reported that the patient had an incident last week when a latex kit was inserted into the patient who had a latex allergy.The central supply manager at the hospital stated that it was due to human error on a few different levels.The hospital struggled with being able to easily identify those kits quickly, because before the kits that were latex free had "nrl" on the front, but now there is not an easy identifier.Per additional information received from the central supply manager on 11oct2019, the hospital stated that the staff incorrectly placed the non-latex sticker on the kit.The supply manager stated this was allowing too much room for human error by having to place the stickers on the kits because nursing was having a difficult time identifying the products.The hospital asked if bard is doing anything to address it.Per additional information received from the central supply manager on 16oct2019, she confirmed that the caution statement was on the side of the kit.The patient received medication in the hospital for the latex reaction.The name of the medication was currently not known.
Additional Manufacturer Narrative
The reported event was confirmed as user-related.Visual inspection noted two photo samples were received.The event inferred that once the products reached the hospital, the nurses relabeled the products with their own label to help identify latex and non-latex products.Visual evaluation noted one of the photo samples had one product with the "non-nrl" label on it properly relabeled with a "non-latex" sticker.The photo also showed two samples that did not have the "non-nrl" label with the proper "this product contains latex" stickers.The other photo sample showed a foley tray without the "non-nrl" label improperly relabeled with a "non-latex" sticker.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "caution this product contains natural rubber latex which may cause allergic reactions.".
Event or Problem Description
It was reported that the patient had an incident last week when a latex kit was inserted into the patient who had a latex allergy.The central supply manager at the hospital stated that it was due to human error on a few different levels.The hospital struggled with being able to easily identify those kits quickly, because before the kits that were latex free had "nrl" on the front, but now there is not an easy identifier.Per additional information received from the central supply manager on 11oct2019, the hospital stated that the staff incorrectly placed the non-latex sticker on the kit.The supply manager stated this was allowing too much room for human error by having to place the stickers on the kits because nursing was having a difficult time identifying the products.The hospital asked if bard is doing anything to address it.Per additional information received from the central supply manager on 16oct2019, she confirmed that the caution statement was on the side of the kit.The patient received medication in the hospital for the latex reaction.The name of the medication was currently not known.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: SURESTEP FOLEY KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9290431
• Report Number: 1018233-2019-07124
• Device Sequence Number: 19376333
• Product Code: EZC
• UDI-Device Identifier: 00801741074004
• UDI-Public: (01)00801741074004
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: A899914
• Device Catalogue Number: A899914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention