BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
Report
- Report Number
- 1920898-2021-01394
- Event Type
- Malfunction
- Date Received
- January 12, 2022
- Date of Event
- December 16, 2021
- Report Date
- February 24, 2022
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- PMA / PMN Number
- K170386
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2022-02-07. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (10) 1ML BD INSULIN SYRINGES IN AN UNOPENED POLYBAG FROM LOT# 1193441. THE CUSTOMER REPORTED THAT THE NEEDLE BROKE OFF AT THE HUB, NEEDLES WERE FLIMSY, AND NEEDLE WERE BENT WHEN REMOVING THE NEEDLE SHIELD. THE RETURNED SYRINGES WERE EXAMINED, AND IT WAS OBSERVED THAT NONE OF THE CANNULAS WERE BENT AFTER THE CANNULA SHIELDS WERE REMOVED. THE SYRINGES WERE THEN TESTED FOR NEEDLE LENGTH, POINT GEOMETRY, OUTER DIAMETER AND LUBE COVERAGE. ALL TESTED SAMPLES MEASURED WITHIN SPECIFICATION. NO DEFECTS WERE OBSERVED, THEREFORE, THE ALLEGED DEFECT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1193441. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H10.
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# 1193441. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT 1 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED 1 NEEDLE THAT BROKE OFF AT THE HUB AND JUST THE CANNULA AND STAYED IN THE SKIN SITE. THE CONSUMER WAS ABLE TO REMOVE WITH FINGER NAILS. DATE OF EVENT : (B)(6) 2021. SAMPLE STATUS : DISCARDED.
IT WAS REPORTED THAT 1 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED 1 NEEDLE THAT BROKE OFF AT THE HUB AND JUST THE CANNULA AND STAYED IN THE SKIN SITE. THE CONSUMER WAS ABLE TO REMOVE WITH FINGER NAILS. DATE OF EVENT : (B)(6) 2021; SAMPLE STATUS : DISCARDED.
IT WAS REPORTED THAT 1 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED 1 NEEDLE THAT BROKE OFF AT THE HUB AND JUST THE CANNULA AND STAYED IN THE SKIN SITE. THE CONSUMER WAS ABLE TO REMOVE WITH FINGER NAILS. DATE OF EVENT : (B)(6) 2021. SAMPLE STATUS : DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1102194 | BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 1193441 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |