SYRINGE 0.5ML 31G TW 6MM BLS 400 SG
Report
- Report Number
- 1920898-2019-01002
- Event Type
- Malfunction
- Date Received
- September 17, 2019
- Date of Event
- August 27, 2019
- Report Date
- October 15, 2019
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- MEG
- PMA / PMN Number
- K992734
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION: CUSTOMER RETURNED (3) 1ML, 6MM, 31G BD SAFETYGLIDE INSULIN SYRINGES IN SEALED BLISTER PACKS (2 FROM LOT # 9063603, 1 FROM LOT # 9015893). CUSTOMER STATES THAT THE LUBRICANT FROM THE NEEDLE IS MAKING ITS WAY INTO THE INSULIN VIAL AND CAUSING TURBIDITY/FLOATERS WITHIN THE VIAL. ALL RETURNED SYRINGES WERE EXAMINED AND NO FOREIGN MATTER, EXCESS LUBRICATION, OR ANY OTHER MATERIAL WAS OBSERVED IN OR ON ANY PART OF THE SYRINGES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9106719. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9106720. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9015893. ALL INSPECTIONS 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# 9063603. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9084819. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H.10.
INVESTIGATION: 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# 9106719. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9106720. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9015893. ALL INSPECTIONS 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# 9063603. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9084819. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.
THE CHANGES ARE AS FOLLOWS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 9106719. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-04-16. MEDICAL DEVICE LOT #: 9106720. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-04-16. MEDICAL DEVICE LOT #: 9063603. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2019-03-04. MEDICAL DEVICE LOT #: 9063603 MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2019-03-25. MEDICAL DEVICE LOT #: 9015893. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. DEVICE MANUFACTURE DATE: 2019-01-15.
IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A SYRINGE 0.5ML 31G TW 6MM BLS 400 SG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I AM REACHING OUT DUE TO REPORTS WE HAVE RECEIVED AT A FEW OF OUR FACILITIES RELATED TO THE INSULIN SYRINGES LISTED BELOW. THERE HAS BEEN SOME CONCERN THAT THE LUBRICANT FROM THE NEEDLE IS MAKING ITS WAY INTO THE INSULIN VIAL AND CAUSING TURBIDITY/FLOATERS WITHIN THE VIAL. IS THIS SOMETHING THAT HAS BEEN REPORTED IN THE PAST? IS THERE SOMEONE THAT I COULD SPEAK WITH REGARDING THIS CONCERN."
IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A SYRINGE 0.5ML 31G TW 6MM BLS 400 SG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I AM REACHING OUT DUE TO REPORTS WE HAVE RECEIVED AT A FEW OF OUR FACILITIES RELATED TO THE INSULIN SYRINGES LISTED BELOW. THERE HAS BEEN SOME CONCERN THAT THE LUBRICANT FROM THE NEEDLE IS MAKING ITS WAY INTO THE INSULIN VIAL AND CAUSING TURBIDITY/FLOATERS WITHIN THE VIAL. IS THIS SOMETHING THAT HAS BEEN REPORTED IN THE PAST? IS THERE SOMEONE THAT I COULD SPEAK WITH REGARDING THIS CONCERN."
IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A SYRINGE 0.5ML 31G TW 6MM BLS 400 SG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I AM REACHING OUT DUE TO REPORTS WE HAVE RECEIVED AT A FEW OF OUR FACILITIES RELATED TO THE INSULIN SYRINGES LISTED BELOW. THERE HAS BEEN SOME CONCERN THAT THE LUBRICANT FROM THE NEEDLE IS MAKING ITS WAY INTO THE INSULIN VIAL AND CAUSING TURBIDITY/FLOATERS WITHIN THE VIAL. IS THIS SOMETHING THAT HAS BEEN REPORTED IN THE PAST? IS THERE SOMEONE THAT I COULD SPEAK WITH REGARDING THIS CONCERN."
(B)(6). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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. UNABLE TO PERFORM DHR CHECK FOR FOREIGN MATTER (FLOATERS IN VIAL) DUE TO UNKNOWN LOT NUMBER. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.
IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A SYRINGE 0.5ML 31G TW 6MM BLS 400 SG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I AM REACHING OUT DUE TO REPORTS WE HAVE RECEIVED AT A FEW OF OUR FACILITIES RELATED TO THE INSULIN SYRINGES LISTED BELOW. THERE HAS BEEN SOME CONCERN THAT THE LUBRICANT FROM THE NEEDLE IS MAKING ITS WAY INTO THE INSULIN VIAL AND CAUSING TURBIDITY/FLOATERS WITHIN THE VIAL. IS THIS SOMETHING THAT HAS BEEN REPORTED IN THE PAST? IS THERE SOMEONE THAT I COULD SPEAK WITH REGARDING THIS CONCERN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 872875 | SYRINGE 0.5ML 31G TW 6MM BLS 400 SG | SYRINGE, ANTISTICK | MEG | BD MEDICAL - DIABETES CARE | SEE H.10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |