MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® FOLEY CATHETER INSERTION TRAY; FOLEY TRAY KIT

Model Number 802010

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.

Event Description

It was reported that two of the kits were missing the lubricant.No medical intervention was required.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿missing components¿ with a potential root cause of ¿machine speed out of parameters¿.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: "contents: ¿ povidone-iodine swabs ¿ waterproof underpad ¿ drape ¿ 10cc syringe (prefilled with sterile water) ¿ gloves ¿ lubricant ¿ graduated collection container".

Event Description

It was reported that two of the kits were missing the lubricant.No medical intervention was required.

• Brand Name: BARDIA® FOLEY CATHETER INSERTION TRAY
• Type of Device: FOLEY TRAY KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8549973
• MDR Text Key: 143266702
• Report Number: 1018233-2019-02169
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 00801741018282
• UDI-Public: (01)00801741018282
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

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: Lay User/Patient
• Device Expiration Date: 09/30/2021
• Device Model Number: 802010
• Device Catalogue Number: 802010
• Device Lot Number: NGCZ3505
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 05/21/2019
• Supplement Dates FDA Received: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1