SYRINGE ORAL 5ML CLEAR
Received Mar 24, 2020 · Event occurred Mar 4, 2020
Report 1213809-2020-00202 · MDR key 9873656
Device
Generic name
Liquid Medication Dispenser
Manufacturer
Becton Dickinson Medical SystemsCatalog number
305218
Lot number
UNKNOWN
Product problems
- Device Contamination with Chemical or Other Material
- Device Contamination with Chemical or Other Material
Patient
21 MO
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT SYRINGE ORAL 5ML CLEAR CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CUSTOMER RECEIVED ONE OF THE 5ML SYRINGES FROM THE PHARMACY FOR THEIR 21 MONTH OLD CHILD' S LIQUID MEDICATION AND THE INK CAME OFF OF IT WHEN IT CAME IN CONTACT WITH THE LIQUID MEDICATION AND LEACHED INTO THE MEDICINE, WHICH THE CUSTOMER BELIEVES THAT THEIR CHILD INGESTED. VERBATIM: FROM PHONE CALL ON 2020-03-04 17:24:52: RECEIVED MESSAGE FROM REPRESENTATIVE, CONSUMER WAS ON PHONE. REP ATTEMPTED TO TRANSFER CALL, BUT IT WAS NOT SUCCESSFUL. TRIED TO REACH CONSUMER TWICE BUT CALL DID NOT CONNECT. SENT EMAIL TO CONSUMER INFORMING HER I WAS TRYING TO REACH HER. "
Description of Event or Problem
IT WAS REPORTED THAT SYRINGE ORAL 5ML CLEAR CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CUSTOMER RECEIVED ONE OF THE 5ML SYRINGES FROM THE PHARMACY FOR THEIR 21 MONTH OLD CHILD' S LIQUID MEDICATION AND THE INK CAME OFF OF IT WHEN IT CAME IN CONTACT WITH THE LIQUID MEDICATION AND LEACHED INTO THE MEDICINE, WHICH THE CUSTOMER BELIEVES THAT THEIR CHILD INGESTED. VERBATIM: FROM PHONE CALL ON (B)(6)2020 17:24:52: RECEIVED MESSAGE FROM REPRESENTATIVE, CONSUMER WAS ON PHONE. REP ATTEMPTED TO TRANSFER CALL, BUT IT WAS NOT SUCCESSFUL. TRIED TO REACH CONSUMER TWICE BUT CALL DID NOT CONNECT. SENT EMAIL TO CONSUMER INFORMING HER I WAS TRYING TO REACH HER. "
Additional Manufacturer Narrative
H.6. INVESTIGATION SUMMARY: ONE PHOTO OF A LOOSE 5ML CLEAR ORAL SYRINGE WAS RECEIVED AND EVALUATED. NO DEFECTS WERE OBSERVED IN THE PHOTO. BASED ON THE VERBATIM, IT APPEARS THE DEVICE WAS POTENTIALLY MISUSED WHEN MEDICATION CAME IN CONTACT WITH THE INK THAT MAY HAVE RESULTED IN THE PATIENT INGESTING IT. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE PHOTO RECEIVED.