BD AUTOSHIELD DUO SAFETY PEN NEEDLE
Report
- Report Number
- 9616656-2020-00621
- Event Type
- Malfunction
- Date Received
- July 2, 2020
- Date of Event
- June 12, 2020
- Report Date
- September 4, 2020
- Manufacturer
- BECTON DICKINSON AND CO.
- Product Code
- FMI
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION: NO SAMPLES OR PHOTOS WERE RETURNED FOR ANALYSIS. NO DHR REVIEW CAN BE CARRIED OUT AS LOT NUMBER IS UNKNOWN. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.
CORRECTION: LOT NUMBERS WERE PROVIDED BY THE CUSTOMER. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 2 BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE IN LOT 9288381, AND 2 NEEDLES IN LOT 9121516, WERE FOUND CLOGGED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "NEEDLE CLOG WAS FOUND FOR 3 PEN NEEDLES." THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 9288381. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-10-31. H.4. DEVICE MANUFACTURE DATE: 2019-10-15. D.4. MEDICAL DEVICE LOT #: 9121516. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. H.4. DEVICE MANUFACTURE DATE: 2019-05-01.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVALUATION?: YES. D.10. RETURNED TO MANUFACTURER ON: (B)(6)2020. H.6. INVESTIGATION: TWO OPEN 32G X 6MM PEN NEEDLE SAMPLE WERE RETURNED FROM LOT. NO. 9288381 ALONG WITH TWO OPEN 32G X 6MM PEN NEEDLES FROM LOT. NO. 9121516, CAT. NO. 320738. VISUAL EXAMINATION WAS CARRIED OUT ON ALL FOUR SAMPLES AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON ALL FOUR SAMPLES. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS ALL SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED.
IT WAS REPORTED THAT THE BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE WAS CLOGGED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "NEEDLE CLOG WAS FOUND FOR 3 PEN NEEDLES."
IT WAS REPORTED THAT 2 BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE IN LOT 9288381, AND 2 NEEDLES IN LOT 9121516, WERE FOUND CLOGGED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "NEEDLE CLOG WAS FOUND FOR 3 PEN NEEDLES."
IT WAS REPORTED THAT 2 BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE IN LOT 9288381, AND 2 NEEDLES IN LOT 9121516 WERE FOUND CLOGGED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "NEEDLE CLOG WAS FOUND FOR 3 PEN NEEDLES."
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. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).
IT WAS REPORTED THAT THE BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE WAS CLOGGED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "NEEDLE CLOG WAS FOUND FOR 3 PEN NEEDLES."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 686514 | BD AUTOSHIELD DUO SAFETY PEN NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON AND CO. | SEE SECTION H.10. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |