BD MICRO-FINE¿+ PRO PEN NEEDLE
Report
- Report Number
- 9616656-2022-00037
- Event Type
- Malfunction
- Date Received
- January 25, 2022
- Date of Event
- January 6, 2022
- Report Date
- February 23, 2022
- 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
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 2/15/2022 . H.6. INVESTIGATION: TWO OPEN 32G X 4MM PEN NEEDLE SAMPLES AND FOUR PHOTOS WERE RETURNED FROM LOT. NO. 1012832, CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON BOTH SAMPLES. DUE TO THE CONDITION THE SAMPLES WERE RECEIVED NO CLOG TESTING COULD BE CARRIED OUT. 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. AS THE SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED H3 OTHER TEXT : SEE H.10.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6. INVESTIGATION: 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. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED WHEN USING THE BD MICRO-FINE¿+ PRO PEN NEEDLE, THE DEVICE EXPERIENCED THE INABILITY TO DELIVER INSULIN. THIS EVENT OCCURRED TWO TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ACCORDING TO THE PATIENT'S REPORT, THE PEN NEEDLE WAS ATTACHED TO THE PEN BUT THE DRUG SOLUTION DIDN'T COME OUT. THIS OCCURRED IN TWO PRODUCTS.
IT WAS REPORTED WHEN USING THE BD MICRO-FINE¿+ PRO PEN NEEDLE, THE DEVICE EXPERIENCED THE INABILITY TO DELIVER INSULIN. THIS EVENT OCCURRED TWO TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ACCORDING TO THE PATIENT'S REPORT, THE PEN NEEDLE WAS ATTACHED TO THE PEN BUT THE DRUG SOLUTION DIDN'T COME OUT. THIS OCCURRED IN TWO PRODUCTS.
IT WAS REPORTED WHEN USING THE BD MICRO-FINE¿+ PRO PEN NEEDLE, THE DEVICE EXPERIENCED THE INABILITY TO DELIVER INSULIN. THIS EVENT OCCURRED TWO TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ACCORDING TO THE PATIENT'S REPORT, THE PEN NEEDLE WAS ATTACHED TO THE PEN BUT THE DRUG SOLUTION DIDN'T COME OUT. THIS OCCURRED IN TWO PRODUCTS.
IT WAS REPORTED WHEN USING THE BD MICRO-FINE¿+ PRO PEN NEEDLE, THE DEVICE EXPERIENCED THE INABILITY TO DELIVER INSULIN. THIS EVENT OCCURRED TWO TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ACCORDING TO THE PATIENT'S REPORT, THE PEN NEEDLE WAS ATTACHED TO THE PEN BUT THE DRUG SOLUTION DIDN'T COME OUT. THIS OCCURRED IN TWO PRODUCTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 746289 | BD MICRO-FINE¿+ PRO PEN NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON AND CO. | 1012832 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |