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

Model Number 129414M

Device Problems Disconnection (1171); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2021

Event Type  malfunction  

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 the foley catheter in some of the trays were stuck to the line which caused holes and dents in the foley itself.Per additional information received on (b)(6) 2021, it was reported that there were 3 foley catheters that came apart at the red seal when attempted to flush due to change in output.One of the 3 pilot balloon would not deflate and was removed from patient with balloon inflated.Staff tried to deflate and even cut the side lumen, but it still did not release the water.

Manufacturer Narrative

The reported event was confirmed as use-related.Visual evaluation noted one eggshell 3 way foley catheter was returned.The catheter was returned without the other tray components.As flushing the catheter through the sample port connector is considered off label use, the event will be confirmed as use related.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "slowly aspirate urine sample into syringe and remove syringe from sample port." 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 actual/suspected device was inspected.

Event Description

It was reported that the foley catheter in some of the trays were stuck to the line which caused holes and dents in the foley itself.Per additional information received on 07apr2021, it was reported that there were 3 foley catheters that came apart at the red seal when attempted to flush due to change in output.One of the 3 pilot balloon would not deflate and was removed from patient with balloon inflated.Staff tried to deflate and even cut the side lumen, but it still did not release the water.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® I.C. COMPLETE CARE FOLEY CATHETER
• Type of Device: SURESTEP FOLEY TRAY SYSTEM
• 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: 11753904
• MDR Text Key: 248236261
• Report Number: 1018233-2021-02486
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741046322
• UDI-Public: (01)00801741046322
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Model Number: 129414M
• Device Catalogue Number: A319414AM
• Device Lot Number: NGEZ2590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2021
• 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): Other
• Patient Sex: Female