SYRINGE 0.3ML 31GA 6MM WHOLEUNIT
Report
- Report Number
- 1920898-2020-00279
- Event Type
- Malfunction
- Date Received
- March 19, 2020
- Date of Event
- February 28, 2020
- Report Date
- May 6, 2020
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00382903249091
- PMA / PMN Number
- K024112
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION: NO SAMPLES WERE RETURNED AS OF 3 APRIL 2020 THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. CUSTOMER PROVIDED TWO PHOTOS OF A BD INSULIN SYRINGE SHELF CARTON FROM LOT 9063708. CONSUMER REPORTED THAT THERE IS THERE IS LIQUID ON THE NEEDLE TIP. NO PHOTOS OF A SYRINGE EXHIBITING THE REPORTED DEFECT WERE PROVIDED. SINCE NO EVIDENCE OF A DEFECT WAS OBSERVED THE ALLEGED ISSUE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9063708. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE TWO (2) NOTIFICATIONS [200812519, 200813036] 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.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 4/22/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (15) 3/10CC, 6MM, 31G SYRINGES ((B)(4) LOOSE, (B)(4) IN A SEALED POLY BAG) FROM LOT # 9063708. CUSTOMER STATES THAT THERE IS LIQUID ON THE NEEDLE TIP. ALL RETURNED SYRINGES WERE EXAMINED AND (B)(4) OUT OF (B)(4) LOOSE SAMPLES AND (B)(4) OUT OF (B)(4) SAMPLES FROM THE SEALED POLY BAG EXHIBITED A CLEAR DROPLET OF MATERIAL COMING OUT OF THE CANNULA WHEN THE PLUNGER ROD WAS FULLY DEPRESSED. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9063708. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE TWO (2) NOTIFICATIONS [200812519, 200813036] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 1/2CC, SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. ROOT CAUSE: SILICONE GUN NOT FIRING CORRECTLY. L2L DISPATCH #61416 WAS CREATED. CORRECTION: TIGHTENED BRACKET FOR EYE AND REPOSITIONED. RESET AMPLIFIER TO TRIGGER WHEN BARRELS PASS THROUGH EYE. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 31GA 6MM WHOLE UNIT EXPERIENCED FOREIGN MATTER ON THE DEVICE CANNULA/IN THE FLUID PATH. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 324909, BATCH NO. 9063708. EMAIL RECEIVED: 2020-03-10 23:55:27. LOT: 9063708. CATALOG: 324909. DATE OF EVENT: UNKNOWN. CONSUMER STATED, HE'S SEEING ON SOME OF HIS SYRINGES, A SMALL CLEAR DROP OF LIQUID ON NEEDLE TIP. STATED WHEN PUSHING ON PLUNGER PRIOR TO INJECTION, THATS WHEN HE'S SEES THE LIQUID. STATED, HE DOES NOT USE THE SYRINGE IF HE SEES THE LIQUID. CONSUMER WAS NOT AT HOME TO PROVIDE PRODUCT INFORMATION. HE STATES HE HAS PROBABLY DISCARDED 8-10 OF THEM AS A RESULT. ATTEMPTED TO OBTAIN THE ITEM AND LOT NUMBER BUT WAS UNSUCCESSFUL. HE STATED THERE WERE A LOT OF NUMBERS ON THE BOX.
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 31GA 6MM WHOLEUNIT EXPERIENCED FOREIGN MATTER ON THE DEVICE CANNULA/IN THE FLUID PATH. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 324909 BATCH NO. 9063708 EMAIL RECEIVED (B)(6)2020 23:55:27. LOT: 9063708. CATALOG: 324909. DATE OF EVENT: UNKNOWN. CONSUMER STATED, HE'S SEEING ON SOME OF HIS SYRINGES, A SMALL CLEAR DROP OF LIQUID ON NEEDLE TIP. STATED WHEN PUSHING ON PLUNGER PRIOR TO INJECTION, THATS WHEN HE'S SEES THE LIQUID. STATED, HE DOES NOT USE THE SYRINGE IF HE SEES THE LIQUID. CONSUMER WAS NOT AT HOME TO PROVIDE PRODUCT INFORMATION. HE STATES HE HAS PROBABLY DISCARDED 8-10 OF THEM AS A RESULT. ATTEMPTED TO OBTAIN THE ITEM AND LOT NUMBER BUT WAS UNSUCCESSFUL. HE STATED THERE WERE A LOT OF NUMBERS ON THE BOX.
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.
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 31GA 6MM WHOLE UNIT EXPERIENCED FOREIGN MATTER ON THE DEVICE CANNULA/IN THE FLUID PATH. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 324909 BATCH NO. 9063708. EMAIL RECEIVED: 2020-03-10 23:55:27. LOT: 9063708, CATALOG: 324909, DATE OF EVENT: UNKNOWN. CONSUMER STATED, HE'S SEEING ON SOME OF HIS SYRINGES, A SMALL CLEAR DROP OF LIQUID ON NEEDLE TIP. STATED WHEN PUSHING ON PLUNGER PRIOR TO INJECTION, THAT'S WHEN HE'S SEES THE LIQUID. STATED, HE DOES NOT USE THE SYRINGE IF HE SEES THE LIQUID. CONSUMER WAS NOT AT HOME TO PROVIDE PRODUCT INFORMATION. HE STATES HE HAS PROBABLY DISCARDED 8-10 OF THEM AS A RESULT. ATTEMPTED TO OBTAIN THE ITEM AND LOT NUMBER BUT WAS UNSUCCESSFUL. HE STATED THERE WERE A LOT OF NUMBERS ON THE BOX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321666 | SYRINGE 0.3ML 31GA 6MM WHOLEUNIT | SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 324909 | 9063708 | 00382903249091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |