MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. IRRIGATION/UROLOGY SETS; TWO-LINE IRRIGATION SET WITH NON-VENTED SPIKE

Catalog Number 313003

Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)

Patient Problem Rupture (2208)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample or lot number, a thorough sample analysis or batch record review could not be performed.No specific conclusions can be drawn.The reported catalog number is a gravity irrigation tubing set for use with flexible irrigation bags.Per the instructions for use (ifu), when the drip chamber is approximately 1/2 full, "slowly open roller clamp.Ensure all air is expelled from tubing.Close roller clamp.Attach tubing to desired connection.Slowly open roller clamp and adjust for desired flow rate." no adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.If additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: reports the sets have a wider lumen, flow too fast, develop too many bubbles, and the water goes in faster than it can flow out.There was a bladder rupture last week and the doctor eluded that it could have been caused by the tubing.Per follow-up correspondence with the reporting facility, the reporter indicated that the new tubing has a higher flow than what the urology providers are used to.A patient did have a spontaneous bladder rupture, which could have been contributed to many things.The physician said in passing that maybe it was because of the high flow.

• Brand Name: IRRIGATION/UROLOGY SETS
• Type of Device: TWO-LINE IRRIGATION SET WITH NON-VENTED SPIKE
• Manufacturer (Section D): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, dominican republic ; DR
• Manufacturer Contact: eric roden ; las americas industrial park; km22 autopista las americas; santo domingo, dominican republic ; DR ; 5491000
• MDR Report Key: 5733090
• MDR Text Key: 47676469
• Report Number: 9614279-2016-00039
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 313003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2016
• 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
• Patient Outcome(s): Other