ORAL SYRINGE
Report
- Report Number
- 1416980-2022-04681
- Event Type
- Malfunction
- Date Received
- September 8, 2022
- Report Date
- October 7, 2022
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- KYX
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
CORRECTION MADE TO D1: BRAND NAME: ORAL SYRINGE (PREVIOUSLY SUBMITTED AS CUSTOM KIT); CORRECTION MADE TO D2A: COMMON DEVICE NAME: DISPENSER, LIQUID MEDICATION (PREVIOUSLY SUBMITTED AS SET, I.V. FLUID TRANSFER) ; CORRECTION MADE TO D2B: CLASSIFICATION CODE: KYX (PREVIOUSLY SUBMITTED AS (LHI); ADDITIONAL INFORMATION WAS ADDED TO H6 AND H10. H10: 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.
IT WAS REPORTED THAT THE SCALE OF THE PRODUCT'S MEASURING SYRINGE (ORAL LIQUID DISPENSER PROVIDED IN KIT) WORE OUT VERY QUICKLY DURING USE. THIS WAS IDENTIFIED ¿WHEN USING THE MEDICINE (FOR A CHILD) THAT THE SCALE ON THE SYRINGE DISAPPEARED DURING USE.¿ TO REMEDY THE ISSUE, THE CUSTOMER WENT TO THE HEALTH CENTER TO OBTAIN A NEW SYRINGE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1531247 | ORAL SYRINGE | DISPENSER, LIQUID MEDICATION | KYX | BAXTER HEALTHCARE CORPORATION | NA | UNKNOWN | |
| 234551 | ORAL SYRINGE | DISPENSER, LIQUID MEDICATION | KYX | BAXTER HEALTHCARE CORPORATION | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |