MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN SURESTEP FOLEY TRAYS

Catalog Number UNKNOWN

Device Problem Biocompatibility (2886)

Patient Problem Urinary Tract Infection (2120)

Event Date 08/08/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that a patient experienced a cauti (catheter associated urinary tract infection) during use of a foley sure step double tray.The facility also indicated that they did not receive education of the product.Per additional information received via email on 13sep2021 from the complainant, the patient's admitting diagnosis was new onset chf (congestive heart failure) with a history of coronary artery disease, hyperlipidemia, hypertension, and obesity.There was no prior history of urinary tract infections.The catheter was placed on (b)(6) 2021, and the infection was identified on (b)(6) 2021 by a positive urine culture of proteus mirabilis > 100,000 cfu/ml.The foley was removed, and the patient was treated with levofloxacin 500 mg orally daily.

Event Description

It was reported that a patient experienced a caution (catheter associated urinary tract infection) during use of a foley sure step double tray.The facility also indicated that they did not receive education of the product.Per additional information received via email on (b)(6) 2021 from the complainant, the patient's admitting diagnosis was new onset chf (congestive heart failure) with a history of coronary artery disease, hyperlipidemia, hypertension, and obesity.There was no prior history of urinary tract infections.The catheter was placed on (b)(6) 2021, and the infection was identified on (b)(6) 2021 by a positive urine culture of proteus mirabilis > 100,000 cfu/ml.The foley was removed, and the patient was treated with levofloxacin 500 mg orally daily.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "materials of construction are not biocompatible / inadequate biological evaluation".It is unknown whether the device had met relevant specifications.It is unknown whether the product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the foley trays ifus are found to be adequate based on past reviews.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.

• Brand Name: UNKNOWN SURESTEP FOLEY TRAYS
• Type of Device: UNKNOWN SURESTEP FOLEY TRAYS
• 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: 12460015
• MDR Text Key: 271031088
• Report Number: 1018233-2021-05594
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/13/2021
• Supplement Dates Manufacturer Received: 12/29/2021
• Supplement Dates FDA Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 108 KG