Sex: F
Vaccine: MMR
Symptoms: Device connection issue, Occupational exposure to product
Clinical narrative: she accidentally spilled the product on her skin; she accidentally spilled the product on her skin; This non-serious case was reported by a other health professional via sales rep and described the occurrence of occupational exposure while preparing product for administration in a female patient who received MMR (Priorix) (batch number 75S93, expiry date 11-MAY-2024) and (batch number N94P2, expiry date 12-DEC-2025) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced occupational exposure while preparing product for administration (Verbatim: she accidentally spilled the product on her skin) and exposure via skin contact (Verbatim: she accidentally spilled the product on her skin). The outcome of the occupational exposure while preparing product for administration and exposure via skin contact were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-SEP-2023 and 08-SEP-2023 The reporter was a certified medical assistant (CMA) from a pediatric office. They were reporting a PQC (product quality complaint) with Priorix.  They were reporting that there was a problem with the syringe.  The reporter stated that you knew how the syringe and then had the part that spins that attach the needle to, it was like a ring and he part that had the screwed and you go to screw the needle in it and even though you hold the ring, regardless of which way you spin it and if you would go all the way until you were comfortable and it was tight it pops off.  If the syringe was tight, then the needle was loose and if the needle was tight then the syringe was loosen.  That ring pops off all the way and you could pop it back on and tried to start over but the same thing was just going to happen.  The suspect product was not administered. During preparation, after reconstitution the defect was observed.  The reporter stated that change the needle prior to injecting the patient.  The lot of box was GX27P and expiry date was 11th May 2024 Currently there was one unused dose in the box but the reporter was hesitant to use it thought that the same thing might happen again.  She had two other syringes from this same box which had a similar issue of being loose but she was able to successfully administer them by not tightening the needle as tightly as she would have preferred. Those other two syringes were not available for investigation.  The reporter would be returning one suspect syringe with associated needle and empty vial.  The fluid had been lost as during the call the CMA indicated that she accidentally just wasted the reconstituted product.  She said she accidentally spilled the product on her skin (Accidental Exposure), which led to occupational exposure while preparing product for administration and exposure via skin contact. The hypodermic safety needle- never had issues with this type of needle before and luer Lock compatible.  Any defect or damage on the syringe was not noticed. When removing the cap, it was screwed off.  The needle was connected and it was screwed on the luer lock device. A problem was detected when screwing the needle on, the customer did not continue to attempt to screw it on (perhaps stripping the locking mechanism) and it came off, it popped off before tight. The luer lock device began to spin around the syringe cone and hold the luer lock device in place when attaching the needle. Two needle were tried and the first one was not available but the second one would be returned. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.   Upon internal review the case was updated on 22-DEC -2023. Summary of changes: The case was updated from invalid to valid.