PERIFIX®

Description of Event or Problem

ACCORDING TO THE COMPLAINANT A PATIENT WAS TREATED DURING CHILDBIRTH. DURING THE INSERTION OF AN EPIDURAL AND THE ATTEMPTED REMOVAL OF THE EPIDURAL CATHETER, THE TIP OF THE CATHETER WAS SECTIONED, AND PART OF THE CATHETER REMAINED IN THE PATIENT'S EPIDURAL SPACE. THE SECTIONED CATHETER REMAINED IN SITU. REPORTEDLY, IT WAS FOUND THAT THE LOCATION OF THE MARKINGS ON THE CATHETER WAS INCORRECT. THE DISTANCE BETWEEN TWO MARKERS WAS MORE THAN 1 CM WHEN IT SHOULD BE 1 CM BETWEEN EACH MARKER, RAISING THE QUESTION OF A QUALITY DEFECT OR STRETCHING OF THE CATHETER WHEN IT BROKE. AN MRI EXAMINATION REQUESTED IN ORDER TO LOCATE THE PART OF THE CATHETER THAT HAD BEEN SECTIONED AFTER THE PATIENT'S DELIVERY. THE LUMBAR SPINE CT SCAN OF (B)(6) 2024 SHOWED THAT THE EPIDURAL CATHETER WAS LOCATED AT THE LEVEL OF THE RIGHT LATERAL ASPECT OF THE SPINOUS PROCESS OF L3. ITS TIP WAS OUTSIDE THE SPINAL CANAL. AIR BUBBLES WERE PRESENT IN RELATION TO THE PLACEMENT OF THE CATHETER. ABSENCE EPIDURAL HAEMATOMA. NO SOFT TISSUE COLLECTION.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). 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. WE RECEIVED ONE USED PERIFIX ONE CATHETER Ø 0.84 MM 20G OUT OF A PERIFIX 402 SET WITHOUT PACKAGING. THE FOLLOWING INVESTIGATIONS WERE CONDUCTED: VISUAL INSPECTION: THE RECEIVED PERIFIX ONE CATHETER OUT OF THE SET WAS TAKEN TO A VISUAL INSPECTION FOR DAMAGES ACCORDING TO THE TEST METHOD 102002 DAMAGES. DEFINITION OF THE METHOD: DAMAGES ARE VISIBLE CHANGES IN THE ORIGINAL SHAPE OR SURFACE OF PRODUCTS AND PACKAGING CAUSED BY MECHANICAL FORCES AND/OR MANUFACTURING FAULTS. NOMINAL: NO DAMAGE IS ALLOWED THAT ENDANGERS THE PATIENT, IMPEDES THE USE OF THE PART AS INTENDED (E.G. THE IMPAIRMENT OF THE FUNCTION OF A DROP SENSOR), ENDANGERS THE ASSEMBLY OR FUNCTION OF THE COMPONENT, IMPAIRS THE APPEARANCE OF THE COMPONENT. ACTUAL: THE USED PERIFIX ONE CATHETER Ø 0.84 MM 20G IS TORN / SHEARED OFF AND OVERSTRETCHED. THE TORN OFF PART WITH THE CATHETER TIP WAS NOT HANDED OVER BY THE CUSTOMER. THE RECEIVED CATHETER IS APPROX. 981 MM LONG (SHOULD BE 1010 ± 7,5 COMPLETELY). THE SHORN OFF AREA IS SLANTED AND SHOWS A SMOOTH STRUCTURE AND THERE IS A CUT IN THE CATHETER. THE SEPARATED AREA IS SLANTED, AND THE STRUCTURE IS DUE TO THE RETRACTION OF THE CATHETER IN THE CANNULA. IN THE AREA OF THE SEPARATION THE STRUCTURE IS SLANTED AND ARISES DUE TO THE RETRACTION OF THE CATHETER IN THE CANNULA. NOTE: SUCH DAMAGES MAY OCCUR WHEN THE CATHETER WILL BE WITHDRAWN AGAINST THE CANNULA BEVEL AND THEREBY SHEAR OFF. PLEASE SEE INSTRUCTIONS FOR USE: "NEVER PULL THE CATHETER THROUGH THE NEEDLE AS IT MAY OTHERWISE SHEAR OFF." FUNCTIONAL INSPECTION: N.A. PHYSICAL INSPECTION: IN ADDITION, THE OUTER DIAMETER OF THE PERIFIX CATHETER WAS MEASURED ACCORDING TO THE DRAWING. ACTUAL: THE MEASURED VALUE OF THE CATHETER IN THE UNDAMAGED AREA IS WITHIN OUR SPECIFICATIONS. THE MEASURED VALUE OF THE CATHETER IN THE DAMAGED (OVERSTRETCHED) AREA IS NOT WITHIN OUR SPECIFICATIONS. DUE TO THIS OVERSTRETCHING, THE DISTANCE BETWEEN THE MARKINGS IS ALSO GREATER THAN 10 MM. SUMMARY AND ASSESSMENT: WE EXCLUDE A MANUFACTURING FAULT SINCE THE CATHETERS WERE TAKEN TO A 100% EXAMINATION AND THEREFORE NO MECHANICAL DAMAGES OR MANUFACTURING FAULTS ARE ALLOWED. BASED ON THE CONDUCTED INVESTIGATIONS, WE ASSUME OF A PROBLEM DURING THE APPLICATION. THEREFORE, THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED.