BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
Report
- Report Number
- 1920898-2022-00052
- Event Type
- Malfunction
- Date Received
- February 1, 2022
- Date of Event
- January 13, 2022
- Report Date
- February 15, 2022
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- PMA / PMN Number
- K024112
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. INITIAL REPORTER ZIP CODE : (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL? YES. D.9. RETURNED TO MANUFACTURER ON: 2/15/2022. H.6. INVESTIGATION: CUSTOMER RETURNED (8) 3/10CC, 8MM, 31G SYRINGES IN AN OPEN POLY BAG FROM LOT#: 1200339. CUSTOMER STATES THAT WHEN SHE DEPRESSED THE PLUNGER ROD, SHE SAW LIQUID COMING OUT OF THE NEEDLES. ALL RETURNED SYRINGES WERE EXAMINED AND NO MATERIAL WAS OBSERVED IN THE BARRELS OF THE SYRINGES. ALL SYRINGES WERE ALSO TESTED AND NO MATERIAL CAME OUT OF THE CANNULA OF ANY OF THE SYRINGES WHEN THE PLUNGER ROD WAS FULLY DEPRESSED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#: 1200339 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.
DATE OF EVENT: UNKNOWN. INITIAL REPORTER ZIP CODE : (B)(6). 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 10 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES HAD FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER STATED THAT WHEN DEPRESSING THE PLUNGER ROD TO SQUEEZE THE AIR OUT OF ONE OF THE NEW SYRINGES, A CLEAR LIQUID CAME OUT OF THE NEEDLE. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.
IT WAS REPORTED THAT 10 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES HAD FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER STATED THAT WHEN DEPRESSING THE PLUNGER ROD TO SQUEEZE THE AIR OUT OF ONE OF THE NEW SYRINGES, A CLEAR LIQUID CAME OUT OF THE NEEDLE. DATE OF EVENT : UNKNOWN. SAMPLES: AVAILABLE.
IT WAS REPORTED THAT 10 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES HAD FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER STATED THAT WHEN DEPRESSING THE PLUNGER ROD TO SQUEEZE THE AIR OUT OF ONE OF THE NEW SYRINGES, A CLEAR LIQUID CAME OUT OF THE NEEDLE. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 975424 | BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 1200339 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |