BD RELION¿ INSULIN SYRINGE
Report
- Report Number
- 1920898-2018-00523
- Event Type
- Malfunction
- Date Received
- July 20, 2018
- Date of Event
- June 29, 2018
- Report Date
- August 14, 2018
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- PMA / PMN Number
- K024112
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHARMACIST
Narratives
H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (12) LOOSE 1/2CC, 8MM SYRINGES. CUSTOMER STATES THAT WHEN PUSHING INSULIN BACK INTO VIAL TO CLEAR AIR BUBBLES, PARTICLES ARE SEEN GOING BACK INTO THE VIAL MAKING THE INSULIN HAVE A MURKY APPEARANCE. ALL RETURNED SYRINGES WERE EXAMINED AND NO FOREIGN MATTER WAS OBSERVED IN THE BARREL OR ON THE CANNULA OF ANY OF THE SAMPLES. ALSO, NO FOREIGN MATTER CAME OUT OF THE CANNULA WHEN FULLY DEPRESSING THE PLUNGER ROD. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7178872. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7240981. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200711384, 200712021] NOTED FOR DRY BARRELS. THERE WERE FOURTEEN (14) NOTIFICATIONS [200713595, 200713508, 200713790, 200713884, 200711499, 200711351, 200711482, 200714307, 200713504, 200714278, 200711357, 200711724, 200689741, 200690372] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [200716849] NOTED FOR ADHESIVE SPLATTER. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. INVESTIGATION CONCLUSION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.
DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER; DEVICE SINGLE USE?: NO; DEVICE RETURNED TO MANUFACTURER: YES.
INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7178872. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7240981. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED FOR DRY BARRELS. THERE WERE FOURTEEN (14) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR ADHESIVE SPLATTER. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. INVESTIGATION CONCLUSION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.
IT WAS REPORTED THAT THE RELION¿ INSULIN SYRINGE WHEN USED TO PUSH INSULIN BACK INTO VIAL TO CLEAR AIR BUBBLES, PARTICLES ARE SEEN GOING BACK INTO THE VIAL MAKING THE INSULIN HAVE A MURKY APPEARANCE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
IT WAS REPORTED THAT THE RELION INSULIN SYRINGE WHEN USED TO PUSH INSULIN BACK INTO VIAL TO CLEAR AIR BUBBLES, PARTICLES ARE SEEN GOING BACK INTO THE VIAL MAKING THE INSULIN HAVE A MURKY APPEARANCE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
IT WAS REPORTED THAT THE RELION¿ INSULIN SYRINGE WHEN USED TO PUSH INSULIN BACK INTO VIAL TO CLEAR AIR BUBBLES, PARTICLES ARE SEEN GOING BACK INTO THE VIAL MAKING THE INSULIN HAVE A MURKY APPEARANCE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7178872, DEVICE MANUFACTURE DATE: 08/29/2017, MEDICAL DEVICE EXPIRATION DATE: N/A. MEDICAL DEVICE LOT #: 7240981, DEVICE MANUFACTURE DATE: 10/25/2017, MEDICAL DEVICE EXPIRATION DATE: N/A. 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 THE RELION¿ INSULIN SYRINGE WHEN USED TO PUSH INSULIN BACK INTO VIAL TO CLEAR AIR BUBBLES, PARTICLES ARE SEEN GOING BACK INTO THE VIAL MAKING THE INSULIN HAVE A MURKY APPEARANCE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 547829 | BD RELION¿ INSULIN SYRINGE | SYRINGE | FMF | BD MEDICAL - DIABETES CARE | SEE H.10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |