PENCAN®

Description of Event or Problem

ACCORDING TO THE EVENT DESCRIPTION: "THE WHITACRE 25 NEEDLE SHORT, WHICH WAS BROKEN IN A PROCEDURE, CODE 4502019-10 , LOT 24E22H8B02, IS ATTACHED CUSTOMER REPORT. THE PATIENT IS STABLE, THE PATIENT DID NOT SUFFER ANY DAMAGE, THE BROKEN PART WAS REMOVED FROM THE PATIENT."

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). UPON REVIEWING THE PRODUCT PHOTO PROVIDED, THE CANNULA IS DETECTED TO BE BROKEN. THE RETENTION SAMPLE OF PENCAN 25GX3 1/2 (0.53×88MM)-AP/SA WAS EXAMINED. NO ABNORMALITIES WERE OBSERVED THAT COULD POTENTIALLY LEAD TO BREAKAGE. THE STRENGTH OF THE CANNULA PIPE WAS EVALUATED. THE RESULTS CONFIRMED THAT THE PRODUCT MEETS THE SPECIFIED STANDARD. SPECIFICATION: MAXIMUM DEFLECTION: 0.43 MM TEST CONDITIONS: SPAN: 10 MM, TEST LOAD: 7 N RESULT BATCH NO. 24E22H8B02 MEASURED VALUE: 0.312, 0.313 AV. 0.3122 NO ABNORMALITY IT IS CONFIRMED THAT PENCAN 25GX3 1/2 (0.53×88MM)-AP/SA, BATCH NO. 24E22H8B02 HAS PASSED INSPECTION. NO ABNORMALITIES WERE FOUND IN THE MANUFACTURING RECORDS FOR PENCAN 25GX3 1/2 (0.53×88MM)-AP/SA, BATCH NO. 24E22H8B02. IN ADDITION, A RIGIDITY TEST WAS CONDUCTED ON THE CANNULA PIPES OF THE RETENTION SAMPLES, AND THE MEASURED VALUES MET THE SPECIFIED STANDARDS, CONFIRMING THAT THERE WERE NO ISSUES WITH STRENGTH. BASED ON THE ABOVE FINDINGS, IT IS PRESUMED THAT THE FRACTURE IN THIS CASE WAS CAUSED BY THE CANNULA BEING BENT DURING HANDLING. THE DEFECT IS CONSIDERED AS CONFIRMED. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS.