OBTURATOR FOR VENFLON/SAFELON 0.8X25
Received Mar 10, 2021 · Event occurred Feb 5, 2021
Report 1710034-2021-00176 · MDR key 11457618
Device
Generic name
Obutrator
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.Catalog number
394251
Lot number
9121585
Product problems
- Device Markings/Labelling Problem
- Device Markings/Labelling Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED FOUR PHOTOS SHOWING THAT THE DISPENSER BOX DOES NOT HAVE A LABEL, CONFIRMING YOUR REPORTED DEFECT. IT WAS ALSO NOTED THAT NO STICKER RESIDUE OR DAMAGE TO THE DISPENSER WAS PRESENT INDICATING THAT THE DISPENSER LABEL WAS MOST LIKELY NOT PUT ON THE BOX DURING THE PACKAGING PROCESS. THIS WAS EVIDENCE TO SUPPORT MANUFACTURING/ OPERATOR ERROR AS THE MOST LIKELY ROOT CAUSE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.
Description of Event or Problem
IT WAS REPORTED THAT 2 OBTURATORS FOR VENFLON/SAFELON 0.8X25 EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED A COMPLAINT FROM CUSTOMER THAT 2 PRODUCTS WERE MISSING LOT STICKER. UPON RECEIVING THE PRODUCTS FROM THEM (ON 09.02.) WE CHECKED OTHER PRODUCTS FROM THE SAME LOT AND FOUND OUT, THAT IN ONE BOX THERE WERE 2 MORE PRODUCTS WITH MISSING STICKERS, AND 3 WITH STICKERS APPLIED NORMALLY. WE HAD ON STOCK ANOTHER FULL BOX FROM THE SAME LOT BUT ALL PRODUCTS WERE OK.
Additional Manufacturer Narrative
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT 2 OBTURATORS FOR VENFLON/SAFELON 0.8X25 EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED A COMPLAINT FROM CUSTOMER THAT 2 PRODUCTS WERE MISSING LOT STICKER. UPON RECEIVING THE PRODUCTS FROM THEM (ON 09.02.) WE CHECKED OTHER PRODUCTS FROM THE SAME LOT AND FOUND OUT, THAT IN ONE BOX THERE WERE 2 MORE PRODUCTS WITH MISSING STICKERS, AND 3 WITH STICKERS APPLIED NORMALLY. WE HAD ON STOCK ANOTHER FULL BOX FROM THE SAME LOT BUT ALL PRODUCTS WERE OK.