BD ULTRA-FINE II INSULIN SYRINGE
Report
- Report Number
- 1920898-2019-00537
- Event Type
- Malfunction
- Date Received
- June 13, 2019
- Date of Event
- May 29, 2019
- Report Date
- July 19, 2019
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- PMA / PMN Number
- K950466
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 3/10CC, 6MM, 31G SYRINGE IN AN OPEN POLY BAG WITH THE SHELF CARTON FROM LOT # 8113511. CUSTOMER STATES THAT THERE WAS FOREIGN MATTER IN THE SYRINGE. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED DARK MATERIAL ON THE OUTER SURFACE OF THE BARREL. 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 SCALE PRINT INK MIXED WITH SILICONE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8113511. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE THREE (3) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: -CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. AS PER INVESTIGATION COMPLETED BY MANUFACTURING, "ON (B)(6) 2019, (B)(6) RECEIVED (1) 3/10CC, 6MM, 31G SYRINGE IN AN OPEN POLY BAG WITH THE SHELF CARTON FROM LOT # 8113511. THE SAMPLE WAS DECONTAMINATED PER HSTR-17 AND HQA-68 PRIOR TO BEING EVALUATED. A VISUAL EVALUATION OF THE SYRINGES FOUND A SYRINGE WITH SOLID BLACK INK RING FROM THE ZERO LINE TO THE 9 UNIT LINE ON THE SYRINGE. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. DHR, L2L DISPATCHES, LOG BOOK ENTRIES WERE LOOKED AT, NOTHING WAS FOUND PERTAINING TO THIS DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ".
IT WAS REPORTED THAT BD ULTRA-FINE¿ II INSULIN SYRINGE HAD FOREIGN MATTER IN IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 324919 BATCH NO: 8113511. IT WAS REPORTED THAT THE CONSUMER ENCOUNTERED FOREIGN MATERIAL IN THE SYRINGE CONSUMER STATED ONLY 1 SYRINGE AFFECTED. INCIDENT HAPPENED THIS MORNING, ((B)(6) 2019). FOREIGN MATTER INTERNAL. STATED DID NOT USE SYRINGE. TODAY IN THE MORNING I OPENED THE PACKET OF INSULIN SYRINGES TO GIVE SHOT TO SON. I WAS SO SURPRISED TO SEE THE SYRINGE. I AM BD-CUSTOMER SINCE 23 YEARS BECAUSE I TRUST ON QUALITY OF YOUR PRODUCT.
(B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT BD ULTRA-FINE¿ II INSULIN SYRINGE HAD FOREIGN MATTER IN IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 324919 BATCH NO: 8113511. IT WAS REPORTED THAT THE CONSUMER ENCOUNTERED FOREIGN MATERIAL IN THE SYRINGE. CONSUMER STATED ONLY 1 SYRINGE AFFECTED. INCIDENT HAPPENED THIS MORNING, (05/29/19). FOREIGN MATTER INTERNAL. STATED DID NOT USE SYRINGE. TODAY IN THE MORNING I OPENED THE PACKET OF INSULIN SYRINGES TO GIVE SHOT TO SON. I WAS SO SURPRISED TO SEE THE SYRINGE. I AM BD-CUSTOMER SINCE 23 YEARS BECAUSE I TRUST ON QUALITY OF YOUR PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 490332 | BD ULTRA-FINE II INSULIN SYRINGE | INSULIN SYRINGE & NEEDLE | FMF | BD MEDICAL - DIABETES CARE | 8113511 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |