CAP TIP SYR LL/LS STER LF PP BLUE SINGLE

Description of Event or Problem

ADDITIONAL INFORMATION: FOR A SMALL DOSE SUCH AS THIS MEDICATION AT 0.2 ML, THERE COULD BE GREATER THAN 10% OF FLUID LOSS IN THE HEADSPACE OF THE BLUE TIP CAP, WHICH CAN POTENTIALLY UNDERDOSE A PATIENT IF THIS WERE A MORE CRITICALLY IMPACTFUL MEDICATION.

Additional Manufacturer Narrative

(B)(4) FOLLOW UP. A REPORT WAS RECEIVED INDICATING FLUID LOSS IN THE HEADSPACE OF THE BLUE TIP CAP. TO SUPPORT THE INVESTIGATION, TWO PHOTOGRAPHS WERE PROVIDED TO THE QUALITY TEAM FOR EVALUATION. THE IMAGES DEPICT A VIAL WITH TWO SYRINGES POSITIONED ON EITHER SIDE, EACH FITTED WITH A BLUE TIP CAP. NO ADDITIONAL DETAILS COULD BE CONFIRMED FROM THE PHOTOGRAPHS. THE PURPOSE OF THE TIP CAP IS TO PROTECT THE SYRINGE LUER CONNECTION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR MATERIAL NUMBER 305819, LOT 5353564. THE REVIEW IDENTIFIED NO MANUFACTURING OR INSPECTION ISSUES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED CONDITION, AND NO RELATED QUALITY NOTIFICATIONS WERE ASSOCIATED WITH THIS LOT. ALL PRODUCTION ACTIVITIES AND FINAL INSPECTIONS MET APPLICABLE SPECIFICATION REQUIREMENTS. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND THE AVAILABLE PHOTOGRAPHIC EVIDENCE, THE CONDITION DESCRIBED BY THE CUSTOMER COULD NOT BE CONFIRMED.

Description of Event or Problem

THERE WAS NO PATIENT HARM

Description of Event or Problem

THE CUSTOMER OBSERVED LIQUID PRESENT INSIDE THE TIP CAP. ADDITIONAL INFORMATION THERE WAS NO PATIENT HARM AS THIS WAS CAUGHT BY A PHARMACIST AND SUBSEQUENTLY THE TIP CAP WAS CHANGED TO AN ALTERNATIVE TIP CAP BEFORE DISPENSING.

Additional Manufacturer Narrative

H3: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.