BD INSULIN SYRINGE 3/10ML 29G X 8MM
Report
- Report Number
- 1920898-2021-00460
- Event Type
- Malfunction
- Date Received
- April 26, 2021
- Date of Event
- March 29, 2021
- Report Date
- June 9, 2021
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00681131311786
- PMA / PMN Number
- K024112
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- 003
Narratives
INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0132204. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-05-24 H6: INVESTIGATION SUMMARY CUSTOMER RETURNED FIVE SYRINGES WITH A POUCH LABELED FOR 0.3ML, 31 GAUGE, 8MM SYRINGES. THE FIRST SAMPLE WAS RETURNED WITH ITS NEEDLE HUB AND SHIELD SEPARATED FROM THE BARREL OF THE SYRINGE. THIS SEPARATE ISSUE WILL BE COVERED IN PR2989105. THE REMAINING FOUR SYRINGES RECEIVED SHIELD PULL FORCE TESTING. THE PULL FORCES REQUIRED TO REMOVE THE NEEDLE SHIELDS WERE 6.02 LBS, 5.64 LBS, 6.13 LBS, AND 5.21 LBS. THE SPECIFICATION STATES THAT ALL PULL FORCES WITHIN THE RANGE OF 0.85 LBS TO 5.95 LBS ARE ACCEPTABLE. TWO OF THESE SAMPLES TESTED OUTSIDE THE REQUIRED RANGE. NONE OF THE SAMPLES DISASSEMBLED DURING TESTING. WATER WAS DRAWN INTO EACH OF THE SYRINGES. AFTER WAITING FOR PRESSURE TO EQUALIZE WHILE THE SYRINGE FILLED WITH WATER, NO BACKPRESSURE OR AIR BUBBLES WERE NOTED. LIKEWISE, THE WATER COULD BE PUSHED OUT OF THE SYRINGES WITH NO ISSUES. EACH OF THE RETURNED SYRINGES FUNCTIONS AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0132204. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BD WAS UNABLE TO REPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF DIFFICULTY EXPERIENCED WHILE USING THE PLUNGER. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. BD WAS ABLE TO REPLICATE AND CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE SHIELDS NOT DETACHING. CAPA PR1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE.
HOLD FOR C/R 10/3 IT WAS REPORTED THAT PRIOR TO INJECTION WITH BD INSULIN SYRINGE 3/10ML 29G X 8MM INSULIN LEAKS OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE PLUNGER ROD WILL FORCE THE INSULIN OUT BEFORE THE INJECTION.
IT WAS REPORTED THAT PRIOR TO INJECTION WITH BD INSULIN SYRINGE 3/10ML 29G X 8MM INSULIN LEAKS OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE PLUNGER ROD WILL FORCE THE INSULIN OUT BEFORE THE INJECTION.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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 PRIOR TO INJECTION WITH BD INSULIN SYRINGE 3/10ML 29G X 8MM INSULIN LEAKS OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE PLUNGER ROD WILL FORCE THE INSULIN OUT BEFORE THE INJECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 620209 | BD INSULIN SYRINGE 3/10ML 29G X 8MM | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 328512 | 0132204 | 00681131311786 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |