ERBEFLO *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-07-06 for ERBEFLO * manufactured by Byrne Medical.

Event Text Entries

[1272029] Staff opened a package of tubing to set up the room for an endoscopy (three different lot numbers reported on this day). Upon opening the package and before it was used, the rn noticed that the tubing was cracked and separated from the cap. We have seen this problem in the recent past and continue to be in contact with the manufacturer's representative. Multiple lots have been affected. 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. This is an ongoing problem that we are experiencing. The rep has been notified each time staff identifies the problem & all product has been returned to the manufacturer. 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. It is unknown why the tubing is cracked upon opening the package. 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. The uncracked tubing is from the same lots as those that are cracked. There does not appear to be a pattern in the lot numbers for cracked verses uncracked tubing. Endoscopy staff notified the manufacturer and returned the product.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1410809
MDR Report Key1410809
Date Received2009-07-06
Date of Report2009-07-06
Date of Event2009-03-26
Report Date2009-07-06
Date Reported to FDA2009-07-06
Date Added to Maude2009-07-09
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 Received2009-07-06
Returned To Mfg2009-03-26
Model Number*
Catalog Number*
Lot NumberST2008-534; ST208-584
ID Number*
Device AvailabilityR
Device Age1 DY
Device Sequence No1
Device Event Key0
ManufacturerBYRNE MEDICAL
Manufacturer Address3150 POLLOK DRIVE CONROE TX 77303 US 77303


Patients

Patient NumberTreatmentOutcomeDate
10 2009-07-06

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