DISPOZ-A-BAG *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-09-08 for DISPOZ-A-BAG * manufactured by Bard Access Systems.

Event Text Entries

[534613] The patient was in or for cystoscopy, bilateral retrograde pyelograms, left ureteral washing, and transurethral resection of bladder tumor. At the end of the case, the physician inserted an 18 french foley catheter, inflated with 10cc of sterile water. The nurse then attached the disposable leg bag to the foley. The patient was transferred to the recovery room and then to same day surgery. Upon arrival to the same day surgery unit, the receiving rn noted that there was no urine output. The recovery room rn noted that the patient had no urinary output while in pacu. Upon further investigation, the same day surgery rn discovered that the urine collection bag had been put on upside-down so that the foley was connected to the end of the bag with the flip-flo drainage instead of the inlet valve. The urine leg bag was immediately turned so that the foley was connected to the inlet valve. Approximately 200cc of urine was returned. The patient had no complaints of bladder pain/discomfort either prior to or after the bag's position was changed. No harm to the patient and no complications. However, this is the second time we have seen this occur. Interviews with staff found that the nurses involved were experienced staff who had applied leg bags multiple times in the past. The nurses in pacu did not notice that the leg bag had been applied upside down. This is not a new product to our facility. The labeling on the product is very clear, as are the instructions contained in the kit. Of note, the flip-flo valve and the inlet valve are the same size and both easily accommodate fitting into the foley catheters. Staff's suggestion is that perhaps the manufacturer could change the size of the flip-flo valve so that the foley could not fit on it. Additional education has been provided to the nursing staff. The actual leg bag that was used on the patient is not available and the packaging from this patient's leg bag was not saved. However, an example of the product is available in risk management.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 778851
• MDR Report Key: 778851
• Date Received: 2006-09-08
• Date of Report: 2006-09-08
• Date of Event: 2006-08-25
• Report Date: 2006-09-08
• Date Reported to FDA: 2006-09-08
• Date Added to Maude: 2006-11-10
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DISPOZ-A-BAG
• Generic Name: URINARY LEG BAG
• Product Code: EYZ
• Date Received: 2006-09-08
• Model Number: *
• Catalog Number: *
• Lot Number: NGQF2041
• ID Number: *
• Operator: NURSE
• Device Availability: N
• Device Age: 1 DY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 766632
• Manufacturer: BARD ACCESS SYSTEMS
• Manufacturer Address: 100 SOCKANOSSETT CROSSROAD CRANSTON RI 02920 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-09-08