MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BAG,DRAINAGE,UROLOGY,2000ML,ANTI REFLUX

Catalog Number	DYNC1674
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the patient's urine would not drain into the urinary drainage bag resulting in the patient developing bladder distention and urinary tract infection.Per report, the patient's urine was staying in the drainage tubing and back flowed into patient's bladder.Urine culture showed growth of proteus mirabilis (>100,000 cfu/ml) and e.Coli (40,000 cfu/ml).The patient was started on oral levaquin for treatment of uti and the patient's foley catheter and urinary drainage bag was changed.Due to the reported foley catheter change and need for antibiotic treatment of urinary tract infection, this medwatch is being filed.The sample is not available to be returned for evaluation.A root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the patient's urine would not drain into the urinary drainage bag resulting in the patient developing bladder distention and urinary tract infection.
Additional Manufacturer Narrative
The sample was returned by the reporting facility for evaluation.The reported issue of urinary drainage bags not draining, with regards to a product quality issue, was not verified through visual, functional, or dimensional evaluation of the received samples, as no product quality issues were found.Drainage issues could be related to factors during use, such as proper drain bag placement, or the presence of kinks/dependent loops in the tubing.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

• Common Device Name: BAG,DRAINAGE,UROLOGY,2000ML,ANTI REFLUX
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7901600
• Report Number: 1417592-2018-00106
• Device Sequence Number: 19246085
• Product Code: KNX
• UDI-Device Identifier: 10080196840922
• UDI-Public: 10080196840922
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNC1674
• Device Lot Number: 96917110002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention