BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ 6MM X 31G NEEDLE
Report
- Report Number
- 1920898-2021-00955
- Event Type
- Malfunction
- Date Received
- September 3, 2021
- Date of Event
- August 5, 2021
- Report Date
- December 16, 2021
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00382903249114
- PMA / PMN Number
- K024112
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-11-19. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED A TOTAL OF 4 0.5ML SYRINGES WITH NO OTHER IDENTIFICATION AVAILABLE. THE RETURNED SAMPLES WERE INSPECTED TO ENSURE THAT USING THEM WAS AS LEAST HARMFUL AS INTENDED. THE OUTER DIAMETERS OF THE SYRINGE NEEDLES WERE MEASURED AT 0.0105 IN, 0.0103 IN, 0.0103 IN, AND 0.0145 IN. ALL OF THE NEEDLES WERE MEASURED WITHIN ACCEPTABLE OUTER DIAMETERS FOR 31 GAUGE NEEDLES (0.0100 IN TO 0.0105 IN). THE INTEGRITY OF EACH NEEDLE POINT WAS INSPECTED AND NO DEFECTS WERE FOUND. NO DEBRIS WAS FOUND AT THE TIP OF ANY OF THE NEEDLES. LASTLY, FLOUR WAS APPLIED TO THE NEEDLES¿ CANNULAS TO ENSURE THAT LUBRICANT WAS PRESENT. SUFFICIENT LUBRICANT WAS FOUND ON ALL SAMPLES. NO DAMAGE TO THE NEEDLES OF ANY KIND WAS OBSERVED. THE NEEDLES WERE WITHIN SPECIFICATIONS AND DID NOT FEATURE ANY DULLNESS OR BURRS. THE SAMPLES RETURNED ALSO INCLUDED 2 0.5ML SYRINGES WITH THE NEEDLE HUBS SEPARATED FROM THE BODY OF THE SYRINGES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1060364. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. THE 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 MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1060364. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.
IT WAS REPORTED THAT THE TIPS OF A BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ 6MM X 31G NEEDLE HAS LOOSE METAL AND CAUSES PAIN AND ABRASIONS DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE TIP OF THE NEEDLE SEEMS TO FLAKING LOOSE METAL AROUND THE TIP THAT LEADS TO RIPPING OF SKIN AND TISSUE. "I HAVE BEEN A TYPE 2 DIABETIC FOR ABOUT 10 YEARS NOW AND TAKE HUMAN INJECTIONS TWICE A DAY. I CURRENTLY USE 2 SIZES OF YOUR PRODUCTS 1/2ML BY 6MM BY 31G AT NIGHT AND 1ML BY 6MM BY 31G IN MORNING EVERY DAY. THE INJECTION SITE IS LOWER STOMACH AREA AND I DO VARY LOCATION TO MINIMIZE AREA DAMAGE AS MUCH AS POSSIBLE. MY ISSUE WITH YOUR PRODUCT IS POOR QUALITY CONTROL WITH THE TIP OF THE NEEDLES AND IS AN ONGOING DEFECT. MORE AND MORE THERE SEEMS TO BE FLACKING LOOSE METAL AROUND THE TIP THAT LEADS TO RIPPING OF SKIN AND TISSUE AND AFTER YEARS OF THIS I AM GETTING A BIT ANGRY WITH THIS ISSUE NOT GETTING BETTER. YOUR PRODUCT WORKS PERFECTLY WHEN SHARP BUT IN A BOX OF PACKAGES OF 10 NEEDLES I CAN GET ABOUT HALF OF PACKAGES THAT ARE PERFECT, 1/4 THAT ARE OK, AND THE REST I HAVE TO RUB THE NEEDLE ON SOMETHING HARD TO GET THE EXCESS METAL TO FOLLOW THE SAME DIRECTION OF THE NEEDLE PLUNGE OR SOMETIMES THE EXCESS METAL WILL FLAKE OFF. I REALIZE THE MANUFACTURING ISSUES THAT GO WITH GETTING SUCH A SMALL TIP SHARP EVERY TIME BUT ON THE FLIP SIDE YOU MUST ALSO TAKE OWNERSHIP FOR LACK OF A CONSISTENT PRODUCT AND LACK OF QUALITY CONTROL INSPECTION. IF YOU DO HAVE A PASS/FAIL INSPECTION PROCESS I CAN TELL YOU IT IS FAILING. PLEASE LET ME KNOW IF THERE IS ANYTHING I CAN DO ON MY END TO REMOVE THE BYPRODUCT FROM THE TIP MYSELF OR WHAT ELSE I CAN DO TO IMPROVE THE INJECTION PROCESS."
IT WAS REPORTED THAT THE TIPS OF A BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ 6MM X 31G NEEDLE HAS LOOSE METAL AND CAUSES PAIN AND ABRASIONS DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE TIP OF THE NEEDLE SEEMS TO FLAKING LOOSE METAL AROUND THE TIP THAT LEADS TO RIPPING OF SKIN AND TISSUE. "I HAVE BEEN A TYPE 2 DIABETIC FOR ABOUT 10 YEARS NOW AND TAKE HUMAN INJECTIONS TWICE A DAY. I CURRENTLY USE 2 SIZES OF YOUR PRODUCTS 1/2ML BY 6MM BY 31G AT NIGHT AND 1ML BY 6MM BY 31G IN MORNING EVERY DAY. THE INJECTION SITE IS LOWER STOMACH AREA AND I DO VARY LOCATION TO MINIMIZE AREA DAMAGE AS MUCH AS POSSIBLE. MY ISSUE WITH YOUR PRODUCT IS POOR QUALITY CONTROL WITH THE TIP OF THE NEEDLES AND IS AN ONGOING DEFECT. MORE AND MORE THERE SEEMS TO BE FLACKING LOOSE METAL AROUND THE TIP THAT LEADS TO RIPPING OF SKIN AND TISSUE AND AFTER YEARS OF THIS I AM GETTING A BIT ANGRY WITH THIS ISSUE NOT GETTING BETTER. YOUR PRODUCT WORKS PERFECTLY WHEN SHARP BUT IN A BOX OF PACKAGES OF 10 NEEDLES I CAN GET ABOUT HALF OF PACKAGES THAT ARE PERFECT, 1/4 THAT ARE OK, AND THE REST I HAVE TO RUB THE NEEDLE ON SOMETHING HARD TO GET THE EXCESS METAL TO FOLLOW THE SAME DIRECTION OF THE NEEDLE PLUNGE OR SOMETIMES THE EXCESS METAL WILL FLAKE OFF. I REALIZE THE MANUFACTURING ISSUES THAT GO WITH GETTING SUCH A SMALL TIP SHARP EVERY TIME BUT ON THE FLIP SIDE YOU MUST ALSO TAKE OWNERSHIP FOR LACK OF A CONSISTENT PRODUCT AND LACK OF QUALITY CONTROL INSPECTION. IF YOU DO HAVE A PASS/FAIL INSPECTION PROCESS I CAN TELL YOU IT IS FAILING. PLEASE LET ME KNOW IF THERE IS ANYTHING I CAN DO ON MY END TO REMOVE THE BYPRODUCT FROM THE TIP MYSELF OR WHAT ELSE I CAN DO TO IMPROVE THE INJECTION PROCESS."
DATE OF EVENT: 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 THE TIPS OF A BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ 6MM X 31G NEEDLE HAS LOOSE METAL AND CAUSES PAIN AND ABRASIONS DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE TIP OF THE NEEDLE SEEMS TO FLAKING LOOSE METAL AROUND THE TIP THAT LEADS TO RIPPING OF SKIN AND TISSUE. "I HAVE BEEN A TYPE 2 DIABETIC FOR ABOUT 10 YEARS NOW AND TAKE HUMAN INJECTIONS TWICE A DAY. I CURRENTLY USE 2 SIZES OF YOUR PRODUCTS 1/2ML BY 6MM BY 31G AT NIGHT AND 1ML BY 6MM BY 31G IN MORNING EVERY DAY. THE INJECTION SITE IS LOWER STOMACH AREA AND I DO VARY LOCATION TO MINIMIZE AREA DAMAGE AS MUCH AS POSSIBLE. MY ISSUE WITH YOUR PRODUCT IS POOR QUALITY CONTROL WITH THE TIP OF THE NEEDLES AND IS AN ONGOING DEFECT. MORE AND MORE THERE SEEMS TO BE FLACKING LOOSE METAL AROUND THE TIP THAT LEADS TO RIPPING OF SKIN AND TISSUE AND AFTER YEARS OF THIS I AM GETTING A BIT ANGRY WITH THIS ISSUE NOT GETTING BETTER. YOUR PRODUCT WORKS PERFECTLY WHEN SHARP BUT IN A BOX OF PACKAGES OF 10 NEEDLES I CAN GET ABOUT HALF OF PACKAGES THAT ARE PERFECT, 1/4 THAT ARE OK, AND THE REST I HAVE TO RUB THE NEEDLE ON SOMETHING HARD TO GET THE EXCESS METAL TO FOLLOW THE SAME DIRECTION OF THE NEEDLE PLUNGE OR SOMETIMES THE EXCESS METAL WILL FLAKE OFF. I REALIZE THE MANUFACTURING ISSUES THAT GO WITH GETTING SUCH A SMALL TIP SHARP EVERY TIME BUT ON THE FLIP SIDE YOU MUST ALSO TAKE OWNERSHIP FOR LACK OF A CONSISTENT PRODUCT AND LACK OF QUALITY CONTROL INSPECTION. IF YOU DO HAVE A PASS/FAIL INSPECTION PROCESS I CAN TELL YOU IT IS FAILING. PLEASE LET ME KNOW IF THERE IS ANYTHING I CAN DO ON MY END TO REMOVE THE BYPRODUCT FROM THE TIP MYSELF OR WHAT ELSE I CAN DO TO IMPROVE THE INJECTION PROCESS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1317761 | BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ 6MM X 31G NEEDLE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 324911 | 1060364 | 00382903249114 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |