* EIP2 7911-4001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-04-21 for * EIP2 7911-4001 manufactured by Byrne Medical.

Event Text Entries

[15557567] Staff report that they have been opening packages of endoscopy pump tubing to find that the tubing is cracked and broken upon visual inspection and prior to any use. Specifically, staff report that the tubing is not connected to the cap as it should be. Staff have returned four tubing sets from another lot and now are seeing the same problem in a different lot. The rep has been contacted directly by the endoscopy unit staff and informed of this problem. The product is stored in a cabinet on the endoscopy unit. The product remains in its original box until it is needed for a case. This is the only product stored in that cabinet. To our staff's knowledge, the product comes from the manufacturer via the manufacturer's distributor. When it arrives at the hospital, it comes through our receiving dock and then goes directly to endoscopy. Since this event occurred, the endoscopy staff have been in communication with the sales rep. The rep told the staff that the manufacturer has had several facilities complaining of the same findings-cracked tubing upon opening the packaging. The manufacturer believes that the cracks are related directly to the way that the device is packaged in that the tubing is wound too tightly. I have not received any feedback from the manufacturer as of yet.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1369730
• MDR Report Key: 1369730
• Date Received: 2009-04-21
• Date of Report: 2009-04-21
• Date of Event: 2009-03-16
• Report Date: 2009-04-21
• Date Reported to FDA: 2009-04-21
• Date Added to Maude: 2009-04-29
• 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: *
• Generic Name: ENDOSCOPY PUMP TUBING/CAP SET
• Product Code: KQT
• Date Received: 2009-04-21
• Returned To Mfg: 2009-03-16
• Model Number: EIP2
• Catalog Number: 7911-4001
• Lot Number: ST2008-584
• ID Number: *
• Device Expiration Date: 2012-01-01
• Device Availability: R
• Device Age: 1 DY
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BYRNE MEDICAL
• Manufacturer Address: 3150 POLLOK DRIVE CONROE TX 77303 US 77303

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-04-21