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

Catalog Number 33620

Device Problem Hole In Material (1293)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.

Event Description

It was reported that the patient found a hole in the lumen when opening the catheter.

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 patient found a hole in the funnel when opening the catheter.

Manufacturer Narrative

Received 1 unused catheter in open packaging.The reported event was confirmed as user related.Per the visual evaluation, the sample was examined and a hole/cut was found in the drainage funnel.The hole/cut appeared to have been created with scissors, post manufacturing.A manufacturing related root cause could not be assigned to this event.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).

Event Description

It was reported that the patient found a hole in the funnel when opening the catheter.

• Brand Name: BARD® SILASTIC® FOLEY CATHETER
• Type of Device: SILASTIC FOLEY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6564400
• MDR Text Key: 75309381
• Report Number: 1018233-2017-02404
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K951103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2017

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: 11/30/2020
• Device Catalogue Number: 33620
• Device Lot Number: MYZKR645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2017
• Initial Date FDA Received: 05/12/2017
• Supplement Dates Manufacturer Received: Not provided; 10/23/2017
• Supplement Dates FDA Received: 06/26/2017; 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1