BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE
Report
- Report Number
- 1920898-2020-01235
- Event Type
- Injury
- Date Received
- September 16, 2020
- Date of Event
- August 27, 2020
- Report Date
- October 5, 2020
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00382903249107
- PMA / PMN Number
- K024112
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- 003
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.3. DATE OF EVENT: (B)(6) 2020. G.4. DATE RECEIVED BY MANUFACTURER: 8/27/2020.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?: YES. RETURNED TO MANUFACTURER ON: (B)(6) 2020. INVESTIGATION: CUSTOMER RETURNED (7) LOOSE 3/10CC, 6MM SYRINGES. CUSTOMER STATES THAT THE SYRINGES HAVE THE STARTING LINE/MARK THAT ARE NOT AT THE TOP OF THE SYRINGE AND THERE IS ABOUT A 1/2 UNIT SPACE IN BETWEEN THE STARTING MARK AND THE TOP OF THE SYRINGE SO HER SON HAS RECEIVED MORE MEDICATION AND HAS CRASHED. ALL RETURNED SYRINGES WERE TESTED USING THE PLUG GAUGE AND ALL SCALE MARKING PLACEMENTS FELL WITHIN SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0083507 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200884826, 200884828] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.
IT WAS REPORTED THAT THERE WERE SCALE MARKING ISSUES AND HYPOGLYCEMIA OCCURRED DURING USE WITH A BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PARENT STATED SOME OF THE SYRINGES HAVE THE STARTING LINE/MARK THAT ARE NOT AT THE TOP OF THE SYRINGE. STATED THERE IS ABOUT A 1/2 UNIT SPACE IN BETWEEN THE STARTING MARK AND THE TOP OF THE SYRINGE. DUE TO THIS HER SON HAS RECEIVED MORE MEDICATION AND HAS "CRASHED". STATED NO MEDICAL ATTENTION WAS RECEIVED AND SON WILL BE STARTING AN INSULIN PUMP INSTEAD.
IT WAS REPORTED THAT THERE WERE SCALE MARKING ISSUES AND HYPOGLYCEMIA OCCURRED DURING USE WITH A BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PARENT STATED SOME OF THE SYRINGES HAVE THE STARTING LINE/MARK THAT ARE NOT AT THE TOP OF THE SYRINGE. STATED THERE IS ABOUT A 1/2 UNIT SPACE IN BETWEEN THE STARTING MARK AND THE TOP OF THE SYRINGE.DUE TO THIS HER SON HAS RECEIVED MORE MEDICATION AND HAS "CRASHED". STATED NO MEDICAL ATTENTION WAS RECEIVED AND SON WILL BE STARTING AN INSULIN PUMP INSTEAD.
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. (B)(4).
IT WAS REPORTED THAT THERE WERE SCALE MARKING ISSUES AND HYPOGLYCEMIA OCCURRED DURING USE WITH A BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PARENT STATED SOME OF THE SYRINGES HAVE THE STARTING LINE/MARK THAT ARE NOT AT THE TOP OF THE SYRINGE. STATED THERE IS ABOUT A 1/2 UNIT SPACE IN BETWEEN THE STARTING MARK AND THE TOP OF THE SYRINGE. DUE TO THIS HER SON HAS RECEIVED MORE MEDICATION AND HAS "CRASHED". STATED NO MEDICAL ATTENTION WAS RECEIVED AND SON WILL BE STARTING AN INSULIN PUMP INSTEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1005364 | BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 324910 | 0083507 | 00382903249107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |