ERBEFLO * 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 2009-07-10 for ERBEFLO * 7911-4001 manufactured by Byrne Medical.

Event Text Entries

[1105749] This is an ongoing problem. Again today, staff opened a package of tubing to set up the room for an endoscopy. Upon opening the package and before it was used, the rn noticed that the tubing was cracked and separated from the cap. We continue to be in contact with the manufacturer's representative. 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. 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. The device is not exposed to temperature extremes (heat or cold) during shipping, receiving, or storage. The rep is notified each time staff identifies the problem & staff return the affected product to the manufacturer. The rep continues to tell the staff that the cracks are due to the tubing being wrapped too tight when packaged at the manufacturing plant. Staff is frustrated in that they are opening multiple packages before they can find one that is not cracked. There is no other similar product on the market that the staff can use with our equipment. It is only possible to tell if the tubing is cracked once the packaging is opened. Lots that have cracked tubing also have tubing that is not cracked. Endoscopy staff notified the rep. There are other facilities in our area that use this product, and they too are experiencing the same problems. They have been reported to the mfr, and they also have obtained replacement product that contain multiple lots with the same problem.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1416943
MDR Report Key1416943
Date Received2009-07-10
Date of Report2009-07-10
Date of Event2009-07-10
Report Date2009-07-10
Date Reported to FDA2009-07-10
Date Added to Maude2009-07-21
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameERBEFLO
Generic NameENDOSCOPY PUMP TUBING/CAP SET
Product CodeKQT
Date Received2009-07-10
Returned To Mfg2009-07-10
Model Number*
Catalog Number7911-4001
Lot NumberST2009-237
ID Number*
Device AvailabilityR
Device Age1 DY
Device Sequence No1
Device Event Key0
ManufacturerBYRNE MEDICAL
Manufacturer Address3150 POLLOK CONROE TX 77303 US 77303


Patients

Patient NumberTreatmentOutcomeDate
10 2009-07-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.