MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP FOLEY TRAY SYSTEM BARD LUBRI-SIL FOLEY CATHETER TRAY

Model Number A942216

Device Problem Component Missing (2306)

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

Event Date 04/22/2021

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 saline syringe in the foley kit did not have cap and it had only 1cc of saline instead of 10ml.

Event Description

It was reported that the saline syringe in the foley kit did not have cap and it had only 1cc of saline instead of 10 ml.

Manufacturer Narrative

The reported event was inconclusive as no sample returned for evaluation.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.A potential root cause for this failure mode could be due to incorrect operation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not performed due to the labeling could not have prevented the reported failure.The device was not returned.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM BARD LUBRI-SIL FOLEY CATHETER TRAY
• Type of Device: FOLEY CATHETER TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11832043
• MDR Text Key: 250862110
• Report Number: 1018233-2021-02839
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741074110
• UDI-Public: (01)00801741074110
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: A942216
• Device Catalogue Number: A942216
• Device Lot Number: NGFP0743
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other