MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 URINE COLLECTION; UNK DRAIN BAG

Device Problem Restricted Flow rate (1248)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.A potential root cause for this failure could be 'tubing does not meet specification.' per the fmea, this failure falls in a quad q1 residual risk region.A labeling review is not required.The product code for this z10 urine collection product is unknown.Therefore, bd is unable to determine the associated labeling to review.Although the product code is unknown, the z10 urine collection product labeling is found to be adequate based on past reviews.

Event Description

It was reported that the hospital has had 4 instances of drain bags not draining correctly.It was stated that medical staff has to manipulate the drain tube or catheter to get the urine to flow.

• Brand Name: URINE COLLECTION
• Type of Device: UNK DRAIN BAG
• 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: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 9268839
• MDR Text Key: 188067913
• Report Number: 1018233-2019-07001
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/01/2019

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/01/2019
• 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