MAUDE Adverse Event Report: C.R. BARD, INC. (MONCKS) -1030583 SILASTIC BRAND 5CC LATEX FOLEY CATHETER WITH SILICONE-ELASTOMER COATING, SHORT L

Catalog Number 33620

Device Problems Device Operates Differently Than Expected (2913); No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).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.The device was not returned.

Event Description

It was reported that the product would not drain.The nurse placed the suprapubic catheter and it did not drain.The catheter was removed and replaced with another catheter; however, the second catheter also did not drain.The nurse removed the second catheter and placed a third catheter, which drained successfully.

• Brand Name: SILASTIC BRAND 5CC LATEX FOLEY CATHETER WITH SILICONE-ELASTOMER COATING, SHORT L
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (MONCKS) -1030583; 428 power house rd; moncks corner SC 29461
• Manufacturer (Section G): C.R. BARD, INC. (MONCKS) -1030583; 428 power house rd; moncks corner SC 29461
• Manufacturer Contact: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5921281
• MDR Text Key: 54434118
• Report Number: 1018233-2016-01171
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 08/11/2016

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 Catalogue Number: 33620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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