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

Model Number A942214

Device Problem Component Missing (2306)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 catheter tray was missing a catheter.

Manufacturer Narrative

The reported event was confirmed.The device was not used for treatment.Visual evaluation of the returned sample noted one opened (no original packaging), foley tray with iodine leaks throughout the inside of the packaging.Upon inspection, it was noted that there was no catheter connector or catheter within the tray.No missing components are allowed.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be incorrect operation.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: ¿visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use." correction: d10, h3.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.

Event Description

It was reported that the catheter tray was missing a catheter.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRI-SIL® FOLEY CATHETER TRAY
• Type of Device: BARDEX CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9653640
• MDR Text Key: 183118542
• Report Number: 1018233-2020-00692
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741074103
• UDI-Public: (01)00801741074103
• Combination Product (y/n): N
• PMA/PMN Number: K984084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: A942214
• Device Catalogue Number: A942214
• Device Lot Number: NGDU0422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 01/31/2020
• Supplement Dates Manufacturer Received: 02/24/2020
• Supplement Dates FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1