BD GLIDE¿ WITH TBL BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE
Report
- Report Number
- 1920898-2022-00740
- Event Type
- Malfunction
- Date Received
- October 25, 2022
- Date of Event
- September 29, 2022
- Report Date
- January 5, 2023
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 10382903249029
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6: INVESTIGATION SUMMARY NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO PROVIDED. CUSTOMER RETURNED AN IMAGE OF 31GX6MM SYRINGE FROM LOT 1200820. THE CUSTOMER REPORTED THAT ONE SYRINGE WAS FOUND TO BE CONTAMINATED. THE IMAGES WERE EXAMINED AND THERE IS A TRANSLUCENT BEAD OF LIQUID THAT HAS SOLIDIFIED AT THE TIP. THIS MATERIAL MAY BE THE ADHESIVE MEANT TO HOLD THE NEEDLE IN PLACE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 1200820. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE IMAGES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF FOREIGN MATTER ON NEEDLE. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER E-MAIL: 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 FOREIGN MATTER WAS FOUND ON THE NEEDLE OF THE BD GLIDE¿ WITH TBL BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REGULAR USER OF BD GLIDE U 40 INSULIN SYRINGE , FOUND ONE SYRINGE WITH CONTAMINATED NEEDLE, THIS IS SECOND TIME THEY HAVE FOUND IT."
IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE NEEDLE OF THE BD GLIDE¿ WITH TBL BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REGULAR USER OF BD GLIDE U 40 INSULIN SYRINGE , FOUND ONE SYRINGE WITH CONTAMINATED NEEDLE, THIS IS SECOND TIME THEY HAVE FOUND IT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2775985 | BD GLIDE¿ WITH TBL BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 1200820 | 10382903249029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |