BD ULTRA-FINE¿ PEN NEEDLE
Report
- Report Number
- 9616656-2023-00168
- Event Type
- Malfunction
- Date Received
- March 6, 2023
- Date of Event
- February 8, 2023
- Report Date
- June 2, 2023
- Manufacturer
- BECTON DICKINSON AND CO.
- Product Code
- FMI
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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: 26-APR-2023. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (5) UNOPENED PEN NDL 32GA 4MM LOOSE FROM THE LOT# 2110706. IT WAS REPORTED BY THE CONSUMER THAT THE BOX OF ULTRAFINE NANO PRO NEEDLES HAD DIFFERENT SIZES AND SHAPES OF NEEDLES (MIXED PRODUCT) IN THE BOX. ALL THE PEN NEEDLES WERE MEASURED FOR THE NEEDLE LENGTH USING COMPARATOR AND OBSERVED ALL THE CANNULA LENGTHS FALLS WITHIN THE SPECIFIED ACCEPTANCE RANGE (3.8MM TO 4.6MM). HENCE, THE ALLEGED ISSUE COULD NOT BE CONFIRMED BASED ON THE SAMPLES RETURNED FOR THE INVESTIGATION. SAMPLE 1: 4.21MM; SAMPLE 2: 4.34MM; SAMPLE 3: 4.28MM; SAMPLE 4: 4.19MM; SAMPLE 5: 4.25MM. 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 SAMPLE RECEIVED, EMBECTA WAS NOT ABLE TO CONFIRM THE CUSTOMER INDICATED ISSUE. ROOT CAUSE CANNOT BE DETERMINED AS THE ISSUE IS UNCONFIRMED.
H6: 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.
DATE OF EVENT: UNKNOWN. 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.
IT WAS REPORTED THAT THE BOX OF BD ULTRA-FINE¿ PEN NEEDLES CONTAINED NEEDLES OF DIFFERENT SIZES AND SHAPES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WOULD LIKE TO REPORT THAT OUR PT __ COMPLAINED THAT ONE BOX OF BD ULTRAFINE NANO PRO NEEDLES HAD DIFFERENT SIZES AND SHAPES OF NEEDLES IN THAT SPECIFIC BOX.".
IT WAS REPORTED THAT THE BOX OF BD ULTRA-FINE¿ PEN NEEDLES CONTAINED NEEDLES OF DIFFERENT SIZES AND SHAPES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WOULD LIKE TO REPORT THAT OUR PT __ COMPLAINED THAT ONE BOX OF BD ULTRAFINE NANO PRO NEEDLES HAD DIFFERENT SIZES AND SHAPES OF NEEDLES IN THAT SPECIFIC BOX.".
IT WAS REPORTED THAT THE BOX OF BD ULTRA-FINE¿ PEN NEEDLES CONTAINED NEEDLES OF DIFFERENT SIZES AND SHAPES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WOULD LIKE TO REPORT THAT OUR PT COMPLAINED THAT ONE BOX OF BD ULTRAFINE NANO PRO NEEDLES HAD DIFFERENT SIZES AND SHAPES OF NEEDLES IN THAT SPECIFIC BOX.".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 61114 | BD ULTRA-FINE¿ PEN NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON AND CO. | 2110706 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |