NON LATEX MILLER AIR TIP 050012

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06,07 report with the FDA on 2014-08-21 for NON LATEX MILLER AIR TIP 050012 manufactured by Ezem Inc..

Event Text Entries

[4892803] Narrative: case was received from a hospital fluoroscopy and cardiology lead radiographer at bracco (b)(4) ltd. On (b)(4) 2014 and forwarded to (b)(4) (operating on behalf of bracco) on (b)(4) 2014. On (b)(4) 2014, additional information was received from the primary reporter directly at (b)(4). A health professional reports: on (b)(6) 2014, there were 3 incidents of balloon failing to deflate (non-latex miller air tip, system model no. 650012, lot/serial no. (b)(4)) when removing the catheter. Catheters not kept but 1. 5 bags left of the same batch which dept are now reluctant to use. No patients had any adverse consequences as a result of the balloon not deflating. The return of one unused sample of the same batch for investigation has been requested. Outcome: recovered. Further information has been requested. Worldwide case id: (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[12298183] Company comments: a healthcare professional reported that in 3 barium enema tests the balloon failed to deflate while removing the catheter. Generally, during this type of examination, a lubricated enema tip is inserted into the patient's rectum. The tip has a balloon that could be inflated just enough to keep barium from leaking out (of note, not necessarily the balloon should be completely inflated). As reported in the labeling, the deflation of the balloon should be started after completion of fluoroscopy phase of the exam or after the colon is completely filled with barium and should be completed before removing the enema tip. This approach guarantees good imagines during the examination and avoids lesions in extracting a fully inflated balloon. Based on the above and considering that no clinical consequences were reported in the 3 patients, the manufacturer argues that in these cases the balloon was at least partially deflated before removing it. In fact, the removal of a fully inflated balloon would have been quite impossible and would have led to a difficult extraction maneuvers with traumatic lesions of the rectum or anus. In any case, since the information on manufacturer's hands is very scanty, it was decided to have a conservative approach and to report these cases.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2411512-2014-00006
MDR Report Key4077253
Report Source00,01,05,06,07
Date Received2014-08-21
Date of Report2014-07-17
Date of Event2014-07-16
Date Mfgr Received2014-07-17
Date Added to Maude2014-09-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street259 PROSPECT PLAINS ROAD, BLDG H
Manufacturer CityMONROE TWP NJ 08831
Manufacturer CountryUS
Manufacturer Postal08831
Manufacturer Phone8002575181
Manufacturer G1EZEM
Manufacturer Street532 BROADHOLLOW ROAD
Manufacturer CityMELVILLE NY 11747
Manufacturer CountryUS
Manufacturer Postal Code11747
Single Use0
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameNON LATEX MILLER AIR TIP
Generic NameCATHETER RETENTION BARIUM ENEMA WITH BAG
Product CodeFGD
Date Received2014-08-21
Model Number050012
Catalog NumberNI
Lot Number50724360
ID NumberNA
OperatorOTHER
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerEZEM INC.
Manufacturer Address532 BROADHOLLOW ROAD MELVILLE NY 11747 US 11747


Patients

Patient NumberTreatmentOutcomeDate
10 2014-08-21

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