NEEDLE 30GA 7/8IN BSG CLEAR HUB
Report
- Report Number
- 1911916-2024-00174
- Event Type
- Malfunction
- Date Received
- March 12, 2024
- Date of Event
- November 9, 2023
- Report Date
- May 2, 2024
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMI
- UDI-DI
- 50382903028905
- PMA / PMN Number
- K021475
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THE NEEDLE IS CLOGGED. TO AID IN THE INVESTIGATION, THREE SAMPLES WITH NO PACKAGING BLISTERS AND FOUR PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION; EACH NEEDLE EXPELLED THE SOLUTION WITH A NORMAL FLOW. THE PHOTOS SHOW THE INSIDE OF A NEEDLE HUB LOOKING FROM THE BOTTOM UP. NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302890, LOT 3052475. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.
PR (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
(B)(4) FOLLOW UP. IT WAS REPORTED THE NEEDLE IS CLOGGED. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, FOUR PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW THE INSIDE OF A NEEDLE HUB LOOKING FROM THE BOTTOM UP. NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302890, LOT 3052475. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.
NO ADDITIONAL INFORMATION RECEIVED MATERIAL#: 302890, LOT#:3052475. IT WAS REPORTED BY THE CUSTOMER THAT BEING CLOGGED BY THE END USER: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) OVER THE LAST FEW MONTHS: WE HAVE HAD SEVERAL COMPLAINTS REGARDING PN 302890 (SPECIFICALLY FROM PO (B)(4) BEING CLOGGED BY THE END USER. WE WOULD APPRECIATE IF SOMEONE COULD LOOK INTO THIS ISSUE.
MATERIAL#: 302890; LOT#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT BEING CLOGGED BY THE END USER ADDITIONAL INFORMATION: THE LOT IS 3052475. THERE HAVE BEEN NO REPORTED ADVERSE EVENTS.
NO ADDITIONAL INFORMATION RECEIVED. MATERIAL#: 302890, LOT#:3052475. IT WAS REPORTED BY THE CUSTOMER THAT BEING CLOGGED BY THE END USER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED OVER THE LAST FEW MONTHS WE HAVE HAD SEVERAL COMPLAINTS REGARDING PN 302890 (SPECIFICALLY FROM PO (B)(4)) BEING CLOGGED BY THE END USER. WE WOULD APPRECIATE IF SOMEONE COULD LOOK INTO THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1029244 | NEEDLE 30GA 7/8IN BSG CLEAR HUB | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BECTON DICKINSON | 3052475 | 50382903028905 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |