BD SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB
Report
- Report Number
- 1213809-2019-01266
- Event Type
- Malfunction
- Date Received
- December 13, 2019
- Date of Event
- November 28, 2019
- Report Date
- January 14, 2020
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903059240
- PMA / PMN Number
- SEE H.10
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION SUMMARY: THREE PHOTOS AND SEVEN 3ML SYRINGES IN OPENED BLISTER PACKS (P/N 305924) WERE RECEIVED AND EVALUATED. TWO WERE FROM BATCH 7156653, TWO WERE FROM BATCH 7347873, THREE WERE FROM BATCH 6305556, AND ONE WAS FROM 8064678. IT WAS OBSERVED IN THE PHOTO AND PHYSICAL SAMPLES THE "CLEAR FLUID" WAS SILICONE AND WAS THE NORMAL AND EXPECTED AMOUNT PER PRODUCT SPECIFICATION. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER(S) THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE SECTION H.10.
IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB HAS BEEN FOUND EXPERIENCING FIVE OCCURRENCES OF CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT FLUID/LUBRICANT/SUBSTANCE IN THE 3 ML BD SYRINGE. PER CUSTOMER EMAIL: THERE APPEARS TO BE FLUID/LUBRICANT/SUBSTANCE IN THE 3 ML BD SYRINGE WHEN THE NURSE OPENED THE PACKAGE TO TAKE THE SYRINGE OUT PRIOR TO WITHDRAWING VACCINE. THIS HAS HAPPENED TO SEVERAL SYRINGES NOTED BY THIS NURSE.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE. MEDICAL DEVICE TYPE: FMI. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7156653. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2017-06-05. MEDICAL DEVICE LOT #: 8064678. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2018-03-05. MEDICAL DEVICE LOT #: 6305556. MEDICAL DEVICE EXPIRATION DATE: 2021-10-31. DEVICE MANUFACTURE DATE: 2016-10-31. MEDICAL DEVICE LOT #: 8119703. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2018-04-29. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. PMA/510(K)#: K980987 / K951254. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB HAS BEEN FOUND EXPERIENCING FIVE OCCURRENCES OF CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT FLUID/LUBRICANT/SUBSTANCE IN THE 3 ML BD SYRINGE. PER CUSTOMER EMAIL: THERE APPEARS TO BE FLUID/LUBRICANT/SUBSTANCE IN THE 3 ML BD SYRINGE WHEN THE NURSE OPENED THE PACKAGE TO TAKE THE SYRINGE OUT PRIOR TO WITHDRAWING VACCINE. THIS HAS HAPPENED TO SEVERAL SYRINGES NOTED BY THIS NURSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1264957 | BD SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 305924 | SEE H.10 | 30382903059240 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |