FOLYSIL TIEMANN CATH 5/15ML

Description of Event or Problem

ACCORDING TO THE INFO RECEIVED, A PT EXPERIENCED BALLOON BURST A FEW DAYS AFTER INSERTION ON MORE THAN ONE OCCASION.

Additional Manufacturer Narrative

FOUR (4) UNUSED SAMPLES WERE RECEIVED FOR EVAL IN THEIR SEALED PACKAGING. TESTING WAS CONDUCTED, INCLUSIVE OF INFLATION OF THE SAMPLES TO THEIR MAXIMUM VOLUME (I.E. 12 ML) WITH OSMOSED WATER USING A SYRINGE. ALSO, A SIMULATION TEST WAS CONDUCTED OVER 14 DAYS BY PLACING INFLATED BALLOONS IN WATER AT 37 DEGREE C. THESE TESTS DID NOT REVEAL ANY BURSTING OR DEFLATION AFTER THE 14TH DAY OF SIMULATION. THE RESIDUAL VOLUME COLLECTED WAS BETWEEN 11.5 ML & 12 ML, WHICH IS 95.8% AND 100% OF SPECIFIED VOLUME. THE INTERNAL SPECIFICATION FOR MINIMAL VALUE OF RECOVERY IS 75%. THEREFORE, THE SAMPLES MET SPECIFICATIONS. COLOPLAST WAS UNABLE TO REPRODUCE THE ISSUE ON THE RETURNED SAMPLES AND THEREFORE CANNOT CONFIRM THE COMPLAINT AS REPORTED. UPON REVIEW OF THE LOT HISTORY RECORDS, NO DEVIATIONS WERE NOTED. NO ADDITIONAL REPORTS HAVE BEEN RECEIVED FOR THIS LOT.