PENSAR MEDICAL BASIC SERIES DRESSING KIT

Additional Manufacturer Narrative

PENSAR ATTEMPTED TO OBTAIN THE OMITTED INFORMATION. 1. PATIENT INFORMATION A1-A6. 2. B6 RELEVANT TEST LABS - N/A. 3. B7 OTHER RELEVANT HISTORY -N/A. 4. D10 DATE OF CONCOMITANT THERAPY - UNKKNOWN. THE TUBING WAS NOTED TO BE PULLING APART FROM THE CONNECTOR ON SOME PRODUCT. ADDITIONAL PRODUCT PROVIDED TO THE DISTRIBUTOR/USER AS REPLACEMENT. THIS REPORT IS BEING SUBMITTED BASED ON RE-EVALUATION OF REPORTABILITY REQUIREMENTS PER PENSAR CAPA 46.

Description of Event or Problem

CUSTOMER (B)(6)- REPORTED QUALITY ISSUES WITH THE BASIC HYDROPHOBIC LARGE WOUND DRESSING KIT P/N (B)(4), LOT 1623; TUBING WAS OBSERVED TO PULL APART OR BREAK AT THE STINGRAY CONNECTION. TWO UNITS OBSERVED WITH THE POTENTIAL DEFECT WHILE IN USE. AS PATIENT MOVED THE TUBING WAS PULLED APART CREATING A LEAK IN THE DRESSING. PATIENT(S) REQUIRED A NEW WOUND DRESSING. DEVICES WERE NOT RETURNED. REPLACEMENT PRODUCT PROVIDED. NO NONCONFORMANCES NOTED IN DHR REVIEW. CONSERVATIVE DETERMINATION: MDR REPORTABLE