MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 FOLEY TRAYS

Model Number 802010

Device Problems Misassembled (1398); Device Markings/Labelling Problem (2911)

Patient Problems No Patient Involvement (2645); 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 patient ordered a 10cc catheter tray, however, the catheter inside the tray was a 5cc.The complainant confirmed via email on (b)(6) 2019 that the product was mislabeled.The packaging indicated it was a 5cc, however, once opened it was noted that a 10cc catheter was inside.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode for this failure could be" missing components / accessories ".A potential root cause for this failure could be "incorrect operation" the lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the foley tray product labeling was found to be adequate based on past reviews.

Event Description

It was reported that the patient ordered a 10cc catheter tray, however, the catheter inside the tray was a 5cc.The complainant confirmed via email on 22-april-2019 that the product was mislabeled.The packaging indicated it was a 5cc, however, once opened it was noted that a 10cc catheter was inside.

• Brand Name: FOLEY TRAYS
• Type of Device: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8591041
• MDR Text Key: 144571147
• Report Number: 1018233-2019-02374
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741018282
• UDI-Public: (01)00801741018282
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other,user facili
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 802010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 05/08/2019
• Supplement Dates Manufacturer Received: 05/13/2019
• Supplement Dates FDA Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1