BD NANO¿ 2ND GEN PEN NEEDLES
Report
- Report Number
- 9616656-2022-00886
- Event Type
- Malfunction
- Date Received
- August 23, 2022
- Date of Event
- July 28, 2022
- Report Date
- October 5, 2022
- Manufacturer
- BECTON DICKINSON AND CO.
- Product Code
- FMI
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 23-SEP-2022. H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) OPEN 32GX4MM BD PEN NEEDLE WITHOUT A TEAR DROP LABEL ATTACHED. THE CUSTOMER REPORTED NO INSULIN FLOW WHEN TAKING INJECTION. THE RETURNED SAMPLE WAS EXAMINED, AND IT WAS OBSERVED THAT THE NON-PATIENT END (NPE) CANNULA WAS BENT. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON THE SAMPLE. THE BENT NPE CANNULA WOULD PREVENT PROPER FLOW THROUGH THE PEN NEEDLE, HENCE, THE CUSTOMER WOULD THINK THE PEN NEEDLE WAS CLOGGED. SINCE THE SAMPLE WAS RETURNED AFTER USE, THE PROBABLE CAUSE OF THE BENT NPE CANNULA IS USER ERROR WHEN ATTACHING THE PEN NEEDLE TO A PEN INJECTOR. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: - CONFIRMED: EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (NPE CANNULA BENT). COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. THE ROOT CAUSE FOR THIS ISSUE IS USER RELATED. THE NPE CANNULA WAS BENT AFTER THE USER HANDLED THE PEN NEEDLE. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA/SA IS REQUIRED AT THIS TIME.
IT WAS REPORTED THAT WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES HAD TWO BLOCKED NEEDLES IN THE BOX. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED, NO INSULIN FLOW WHEN TAKING INJECTION. STATED, SHE DOES NOT PRIME BEFORE INJECTION. STATED, SHE ONLY PRIMES WHEN SHE STARTS A NEW INSULIN PEN. SENT: THURSDAY, (B)(6) 2022 4:51 PM: I HAVE BEEN USING YOUR PRODUCT FOR MANY YEARS NOW WITH NO ISSUES. THE LAST BOX I PURCHASED HAD TWO BLOCKED NEEDLES IN THE BOX. I HAVE KEPT THE ONE BLOCKED NEEDLE AND THE BOX IT CAME FROM. ARE YOU HAVING PROBLEMS WITH YOUR PRODUCT? I USE BD NANO PRO ULTRA FINE PEN NEEDLES¿.4MMX32 G. LOT NO: 1110204. EXP. 2026-04-30. I THOUGHT YOU SHOULD KNOW ABOUT THIS PROBLEM I'VE HAD.
IT WAS REPORTED THAT WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES HAD TWO BLOCKED NEEDLES IN THE BOX. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED, NO INSULIN FLOW WHEN TAKING INJECTION. STATED, SHE DOES NOT PRIME BEFORE INJECTION. STATED, SHE ONLY PRIMES WHEN SHE STARTS A NEW INSULIN PEN. SENT: THURSDAY, (B)(6) 2022 4:51 PM I HAVE BEEN USING YOUR PRODUCT FOR MANY YEARS NOW WITH NO ISSUES. THE LAST BOX I PURCHASED HAD TWO BLOCKED NEEDLES IN THE BOX. I HAVE KEPT THE ONE BLOCKED NEEDLE AND THE BOX IT CAME FROM. ARE YOU HAVING PROBLEMS WITH YOUR PRODUCT? I USE BD NANO PRO ULTRA FINE PEN NEEDLES¿.4MMX32 G. LOT NO: 1110204. EXP. 2026-04-30. I THOUGHT YOU SHOULD KNOW ABOUT THIS PROBLEM I'VE HAD.
IT WAS REPORTED THAT WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES HAD TWO BLOCKED NEEDLES IN THE BOX. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED, NO INSULIN FLOW WHEN TAKING INJECTION. STATED, SHE DOES NOT PRIME BEFORE INJECTION. STATED, SHE ONLY PRIMES WHEN SHE STARTS A NEW INSULIN PEN. SENT: THURSDAY, JULY 28, 2022 4:51 PM. I HAVE BEEN USING YOUR PRODUCT FOR MANY YEARS NOW WITH NO ISSUES. THE LAST BOX I PURCHASED HAD TWO BLOCKED NEEDLES IN THE BOX. I HAVE KEPT THE ONE BLOCKED NEEDLE AND THE BOX IT CAME FROM. ARE YOU HAVING PROBLEMS WITH YOUR PRODUCT? I USE BD NANO PRO ULTRA FINE PEN NEEDLES¿.4MMX32 G. LOT NO: 1110204. EXP. 2026-04-30. I THOUGHT YOU SHOULD KNOW ABOUT THIS PROBLEM I'VE HAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2494091 | BD NANO¿ 2ND GEN PEN NEEDLES | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BECTON DICKINSON AND CO. | 1110204 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |