FDA.reportPublic FDA data

MAUDE MDR 1624725

MDR report key
1624725
Report number
2411512-2010-00001
Event key
0
Event type
3
Date of event
2010-01-20
Date received
2010-02-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
CHRISTINA SHEIL, MD
Address
701 COLLEGE ROAD EAST PRINCETON NJ 08540 US
Phone
800-800-8002
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MILLER ENEMA AIR TIP WITH RETENTION CUFFNIEZEMFGDNI8816630154R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-02-190

Event Narratives#

D

Patient 1

NARRATIVE: ON (B)(6) 2010: A NURSE WHO IS THE CLINICAL QUALITY VALUE ANALYSIS MANAGER AT THE FACILITY REPORTED. A MILLER ENEMA AIR TIP WITH RETENTION CUFF WAS INSTALLED IN A MENTALLY CHALLENGED, NON-COMMUNICATIVE FEMALE PT WAS PREPARATION FOR AN UNSPECIFIED BARIUM ENEMA DIAGNOSTIC PROCEDURE. THE ATTENDING PHYSICIAN WHO IS A GASTROENTEROLOGIST CHECKED THE INSTILLATION AND GENTLY REINFLATED THE BALLOON RETENTION CUFF WHICH IS HIS USUAL PROCEDURE. THE DOCTOR STATED THE ENEMA TIP "DID NOT FEEL RIGHT". FLUOROSCOPY REVEALED THE TIP HAS BECOME "DISLODGED" IN THE PT. WITH ASSISTANCE OF THE RADIOLOGIST, THE "DISLODGED" PORTION OF THE TIP WAS REMOVED. IT TOOK ABOUT AN HOUR. THE PT HAD NO ADVERSE CONSEQUENCES FROM THE OCCURRENCE. SHE WAS "FINE". ON (B)(6) 2010: THE INITIAL REPORTER (NURSE) PROVIDED ADD'L INFO WHICH SHE OBTAINED FROM THE NURSE WHO WAS DIRECTLY INVOLVED WITH THE PROCEDURE. THIS ADD'L INFO IS BEING PROCESSED AS PART OF THE INITIAL REPORT BY BRACCO. THE ENTIRE ENEMA TIP BECAME DISLODGED AND WENT INTO THE PT. THE ONLY THING LEFT OUTSIDE THE PT WAS THE TUBING THAT CONNECTS TO THE INFLATOR. THE ENEMA TIP BECAME DISLODGED WHILE THE DOCTOR WAS INFLATING THE ENEMA TIP FOR THE SECOND TIME. THE PT WAS SCHEDULED TO UNDERGO A FLUOROSCOPIC SINGLE CONTRAST BARIUM ENEMA. THE INDICATION FOR THE PROCEDURE WAS "OBSTRUCTION/CONSTIPATION". THE PT WAS (B)(6) AND DID HAVE SOME EXTERNAL HEMORRHOIDS. THE BALLOON INFLATOR USED TO INFLATE THE ENEMA TIP CUFF WAS AN EZEM CATALOGUE NUMBER 9529. SAMPLES OF THE SAME LOT OF ENEMA TIP ARE AVAILABLE TO BE RETURNED TO BRACCO. ON (B)(6) 2010: THE REPORTER PROVIDED ADD'L INFO WHICH WAS OBTAINED FROM A RADIOLOGY STAFF MEMBER AT THE FACILITY. THE INFO IS BEING PROCESSED AS PART OF BRACCO'S INITIAL REPORT. THE TUBE FROM THE ENEMA BAG WAS CONNECTED BY THE FACILITIES STAFF TO THE ENEMA TIP PRIOR TO INSERTING THE ENEMA TIP INTO THE PT. IT TOOK APPROXIMATELY 5 TO 7 MINUTES TO RETRIEVE THE ENEMA TIP FROM THE PT. (B)(4).

N

Patient 1

ON (B)(6) 2010, BRACCO RECEIVED THIS REPORT BY TELEPHONE FROM A NURSE WHO IS THE CLINICAL QUALITY VALUE ANALYSIS MANAGER AT THE USER FACILITY. ADD'L INFO HAS BEEN REQUESTED AND BRACCO IS CONDUCTING AN INVESTIGATION OF ITS MANUFACTURING RECORDS AND RETAINS. THE RESULTS OF BRACCO'S INVESTIGATION ARE NOT YET AVAILABLE. ON (B)(6) 2010, ADD'L INFO WAS RECEIVED FROM THE REPORTER. THE ADDITIONAL INFO CLARIFIED THAT THE ENTIRE ENEMA TIP WENT INTO THE PT WHILE THE DOCTOR WAS INFLATING THE ENEMA TIP CUFF FOR A SECOND TIME. THE REPORTER HAS INDICATED THAT SAMPLES OF THE SAME LOT NUMBER OF ENEMA TIP AT THE FACILITY ARE AVAILABLE FOR RETURN TO BRACCO. ARRANGEMENTS ARE BEING MADE FOR RETURN OF THE SAMPLES TO BRACCO. THE RESULTS OF BRACCO'S INVESTIGATION ARE NOT YET AVAILABLE AND ADD'L INFO HAS BEEN REQUESTED FROM THE FACILITY. COMPANY COMMENTS: THE DEVICE DID NOT PERFORM AS INTENDED. IT IS NOT INTENDED FOR THE ENTIRE DEVICE TO GO INTO THE PT. THIS OCCURRENCE NECESSITATED A MEDICAL INTERVENTION TO PREVENT A POTENTIAL SERIOUS INJURY, AND REOCCURRENCE MIGHT LED TO SERIOUS INJURY TO THE PT.