NA

Description of Event or Problem

IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP MICRO-VOLUME EXTENSION SETS LEAKED. THE EVENTS OCCURRED DURING AN UNKNOWN PROCESS STEP IN THE NEONATAL ICU. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

D4: UNIQUE IDENTIFIER (UDI) #: THE LOT NUMBER (10) AND SUBSEQUENT MANUFACTURING DATE (11) ARE UNKNOWN; THEREFORE, THE UDI NUMBER ONLY WILL CONTAIN THE DEVICE IDENTIFIER (01). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

CORRECTION: D4: MODEL #, PREVIOUS H11 DESCRIBING D4 UDI # (THE LOT NUMBER (10) WAS NOT REPORTED; THEREFORE, THE UDI NUMBER WILL ONLY CONTAIN THE DEVICE IDENTIFIER (01)). H11: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.