MAUDE Adverse Event Report: DEFLUX; METAL NEEDLE

Model Number 10-35810

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/18/2013

Event Type  malfunction  

Event Description

Patient had a cystoscopy on (b)(6) 2013.The patient has a history of spina bifida and the bladder was created using part of the bowel and the ureters are more horizontal than vertical.During the cystoscopy, the physician inserted a deflux needle into the abdomen after visualizing the bladder area with a scope inserted into the urinary channel opening on the right side.Due to the anatomy, there was some difficulty entering the ureter to inject the deflux.When it was removed, there was no blood on the needle.The patient experienced bleeding in her urine for six months after this procedure and blood in her diaper.An ultrasound was completed that did not show anything.The patient follow up with urology with a 1 1/2 inch piece of metal that has a pointed tip on the end that compares to the tip of a deflux needle.The parents stated it was found in the patient's diaper.Due to anatomy of the patient, it is possibly a complication of the surgery when the needle was removed to break off in the patient.It is conceivable that when the physician removed the needle they though it was the entire needle, which is approximately 14 inches long.

• Brand Name: DEFLUX
• Type of Device: METAL NEEDLE
• MDR Report Key: 3901703
• MDR Text Key: 20264842
• Report Number: MW5036862
• Device Sequence Number: 1
• Product Code: LNM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-35810
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9 YR
• Patient Weight: 22