BD NANO¿ 2ND GEN PEN NEEDLE
Report
- Report Number
- 9616656-2022-00486
- Event Type
- Malfunction
- Date Received
- April 29, 2022
- Date of Event
- April 15, 2022
- Report Date
- June 2, 2022
- Manufacturer
- BECTON DICKINSON AND CO.
- Product Code
- FMI
- UDI-DI
- 00382903205509
- PMA / PMN Number
- K212015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1103568, MEDICAL DEVICE EXPIRATION DATE: 30-APR-2026, DEVICE MANUFACTURE DATE: 13-APR-2021; MEDICAL DEVICE LOT #: 1132269, MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2026, DEVICE MANUFACTURE DATE: 12-MAY-2021. 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: D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 29-APR-2022. H6: INVESTIGATION SUMMARY : CUSTOMER RETURNED A TOTAL OF 6 USED 4MM, 32 GAUGE NANO PRO PEN NEEDLES. 1 PEN NEEDLE IS FROM LOT 1132269 AND THE REMAINING 5 ARE FROM 1103568. THE PEN NEEDLES WERE VISUALLY INSPECTED PRIOR TO TESTING. THE SINGLE PEN NEEDLE FROM LOT 1132269 WAS FOUND TO HAVE A BENT NEEDLE ON THE NON-PATIENT SIDE OF THE HUB¿S NEEDLE CANNULA. THIS DAMAGE WOULD PREVENT TESTING FOR CLOGS SINCE THE NEEDLE CANNOT PROPERLY ATTACH TO THE PEN. AS A RESULT, THE PEN NEEDLES APPEAR TO BE CLOGGED DURING USE. BASED ON THE DAMAGE PRESENT, THE NEEDLE BENDING MAY HAVE OCCURRED ACCIDENTALLY WHILE THE USER WAS PREPARING THE PEN NEEDLE FOR USE, POTENTIALLY IF THE PEN WAS NOT PROPERLY ALIGNED WITH THE CANNULA. THE REMAINING SAMPLES FROM LOT 1103568 WERE ATTACHED TO A TEST PEN FILLED WITH SALINE. SALINE WAS PUSHED THROUGH THE SYSTEM AND OUT THE DISTAL TIPS OF THE REMAINING PEN NEEDLES. NO ISSUES WERE FOUND WITH THE REMAINING PEN NEEDLES. A LOT HISTORY REVIEW WAS CARRIED OUT AND ERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE SAMPLES RECEIVED, EMBECTA FOUND THAT THE SAMPLE FROM LOT 1132269 HAD A BENT CANNULA ON THE NON-PATIENT SIDE. THIS DAMAGE COULD RESEMBLE THE NEEDLE BEING CLOGGED AS A RESULT OF INSULIN NOT PASSING THROUGH THE NEEDLE. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF A NEEDLE CLOG IN THE SAMPLES RETURNED FROM LOT 1103568. THE ROOT CAUSE OF THE NEEDLES BENDING APPEARS TO BE ACCIDENTAL DAMAGE FROM STRESSES CAUSED BY THE USER DURING ROUTINE USE. THIS WOULD HAVE ALSO GIVEN THE IMPRESSION THAT THE NEEDLE WAS CLOGGED SINCE INSULIN WOULD BE UNABLE TO PASS THROUGH THE CANNULA. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLE WAS CLOGGED DURING FLOW CHECK. THIS EVENT OCCURRED 5 TIMES WITH LOT# 1103568 AND ONCE WITH LOT# 1132269. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOUND THE NEEDLES TO CLOG DURING THE FLOW CHECK.
IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLE WAS CLOGGED DURING FLOW CHECK. THIS EVENT OCCURRED 5 TIMES WITH LOT# 1103568 AND ONCE WITH LOT# 1132269. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOUND THE NEEDLES TO CLOG DURING THE FLOW CHECK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1099827 | BD NANO¿ 2ND GEN PEN NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON AND CO. | 320550 | SEE H.10. | 00382903205509 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |