MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP FOLEY TRAY SYSTEM BARDEX IC COMPLETE CARE

Model Number A303316A

Device Problems Inadequate Instructions for Healthcare Professional (1319); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the 14 fr (red in color) temp probe foley catheter was found instead of the bardex foley catheter tray 16 fr urine meter.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Corrections - d, f h11: section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

Event Description

It was reported that the 14 fr (red in color) temp probe foley catheter was found instead of the bardex foley catheter tray 16 fr urine meter.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be "incorrect/ missing translation; missing instructions; vendor/printer error".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.The lot number was unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because labeling could not have prevented the reported failure.The information provided by bd 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 bd.

Event Description

It was reported that the 14 fr (red in color) temp probe foley catheter was found instead of the bardex foley catheter tray 16 fr urine meter.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM BARDEX IC COMPLETE CARE
• Type of Device: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10826609
• MDR Text Key: 217345694
• Report Number: 1018233-2020-20902
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741073793
• UDI-Public: (01)00801741073793
• Combination Product (y/n): N
• PMA/PMN Number: K040658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A303316A
• Device Catalogue Number: A303316A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other