BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
Report
- Report Number
- 1920898-2021-01311
- Event Type
- Malfunction
- Date Received
- December 15, 2021
- Date of Event
- November 18, 2021
- Report Date
- December 23, 2021
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- PMA / PMN Number
- K170386
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE : UNKNOWN. 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: 2021-12-31. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED 2 POLYBAGS ¿ 1 OPENED, 1 UNOPENED ¿ CONTAINING 0.3ML, 30 GAUGE, 8MM SYRINGES FROM LOT 9210961. THE OPENED POLYBAG CONTAINED 9 SYRINGES. NO OTHER PRODUCT OR PACKAGING TO COMPARE THESE SYRINGES TO WAS PROVIDED. THE ORIGINAL, INTENDED PRODUCT IS UNKNOWN. THE SYRINGES RETURNED WERE INSPECTED AND NO DAMAGE OR DISCREPANCIES WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9210961. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF DIFFERENT SYRINGES BEING INCLUDED, AS ALL SAMPLES OBSERVED ARE THE SAME. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H10.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE : UNKNOWN. 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 2 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES HAD MIXED PRODUCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE RELION CONSUMER REPORTED FINDING TWO PACKAGES IN THE BOX OF 100 THAT ARE DIFFERENT SIZE SYRINGES AND STATED THE INCORRECT SIZE WAS 3/10ML, 30G, 8MM (TWO BAGS). DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE.
IT WAS REPORTED THAT 2 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES HAD MIXED PRODUCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE RELION CONSUMER REPORTED FINDING TWO PACKAGES IN THE BOX OF 100 THAT ARE DIFFERENT SIZE SYRINGES AND STATED THE INCORRECT SIZE WAS 3/10ML, 30G, 8MM (TWO BAGS). DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.
IT WAS REPORTED THAT 2 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES HAD MIXED PRODUCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE RELION CONSUMER REPORTED FINDING TWO PACKAGES IN THE BOX OF 100 THAT ARE DIFFERENT SIZE SYRINGES AND STATED THE INCORRECT SIZE WAS 3/10ML, 30G, 8MM (TWO BAGS). DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1910158 | BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 9210961 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |