MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® SILASTIC® FOLEY CATHETER; SILASTIC FOLEY 5CC

Model Number 33616

Device Problems Inadequate Instructions for Healthcare Professional (1319); Packaging Problem (3007)

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 packaging was labeled for a 16fr 5 cc balloon but there was a 16fr 10cc balloon inside the packaging.

Manufacturer Narrative

The reported event was unconfirmed.No sample was returned however, this 5cc catheter was intended to be inflated with 10 ccs, 5 cc to fill in the inflation lumen and another 5 to inflate the balloon.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿ 5cc balloon: use 10ml sterile water." 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.H3 other text : the device was not returned.

Event Description

It was reported that the packaging was labeled for a 16fr 5 cc balloon but there was a 16fr 10cc balloon inside the packaging.

• Brand Name: BARD® SILASTIC® FOLEY CATHETER
• Type of Device: SILASTIC FOLEY 5CC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9437861
• MDR Text Key: 178622323
• Report Number: 1018233-2019-07820
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741020063
• UDI-Public: (01)00801741020063
• Combination Product (y/n): N
• PMA/PMN Number: K951103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

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: Lay User/Patient
• Device Model Number: 33616
• Device Catalogue Number: 33616
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 01/12/2020
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1