3 ML SLIP TIP WWD SYRINGE BULK NON-STERILE
Report
- Report Number
- 1213809-2019-00985
- Event Type
- Malfunction
- Date Received
- September 30, 2019
- Date of Event
- September 11, 2019
- Report Date
- November 26, 2019
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- PMA / PMN Number
- K980987
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION: TWO PHOTOS OF A LOOSE 3ML SYRINGE WERE RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WERE INDENTATIONS PRESENT ON EACH SIDE OF THE BARREL OUTSIDE THE GRAD LINES AT THE 1ML MARKING. THE DAMAGE WAS REJECTABLE PER PRODUCT SPECIFICATION. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 8092938 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE H.10.
H.6. INVESTIGATION: TWO PHOTOS OF A LOOSE 3ML SYRINGE WERE RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WERE INDENTATIONS PRESENT ON EACH SIDE OF THE BARREL OUTSIDE THE GRAD LINES AT THE 1ML MARKING. THE DAMAGE WAS REJECTABLE PER PRODUCT SPECIFICATION. A PHYSICAL SAMPLE WAS RECEIVED, AND THE EVALUATION WAS CONSISTENT WITH THAT OF THE PHOTOS. : THE INDENTATIONS ON THE BARREL CAUSED A SLIGHT DEFORMATION THAT PREVENTED THE STOPPER FROM FORMING A SEAL WHICH ALLOWED FOR FLUID TO PASS BY. POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. IT IS LIKELY THE RESULT OF THE BARREL BEING CAUGHT IN A DIAL. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.
IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A 3 ML SLIP TIP WWD SYRINGE BULK NON-STERILE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PLEASE BE ADVISED THAT WE HAVE RECEIVED THE ABOVE NOTED COMPLAINT CONCERNING THE 3CC LS PLASTIC SYRINGE COMPONENT WHERE THE CUSTOMER ADVISED THAT THE SYRINGE WAS LEAKING AND MEDICATION WAS COMING OUT FROM THE SIDE OF THE BARREL."
IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A 3 ML SLIP TIP WWD SYRINGE BULK NON-STERILE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PLEASE BE ADVISED THAT WE HAVE RECEIVED THE ABOVE NOTED COMPLAINT CONCERNING THE 3CC LS PLASTIC SYRINGE COMPONENT WHERE THE CUSTOMER ADVISED THAT THE SYRINGE WAS LEAKING AND MEDICATION WAS COMING OUT FROM THE SIDE OF THE BARREL."
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A 3 ML SLIP TIP WWD SYRINGE BULK NON-STERILE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PLEASE BE ADVISED THAT WE HAVE RECEIVED THE ABOVE NOTED COMPLAINT CONCERNING THE 3CC LS PLASTIC SYRINGE COMPONENT WHERE THE CUSTOMER ADVISED THAT THE SYRINGE WAS LEAKING AND MEDICATION WAS COMING OUT FROM THE SIDE OF THE BARREL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 931532 | 3 ML SLIP TIP WWD SYRINGE BULK NON-STERILE | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 8092938 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |