NEEDLE 30GA 7/8IN BSG CLEAR HUB
Report
- Report Number
- 1911916-2024-00256
- Event Type
- Malfunction
- Date Received
- April 12, 2024
- Date of Event
- March 26, 2024
- Report Date
- May 7, 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
(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. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.
PR (B)(4) FOLLOW UP. IT WAS REPORTED THERE WAS EPOXY IN THE FLUID PATH. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, THREE PHOTOS WITH MAGNIFICATION WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A NEEDLE HUB VIEW FROM THE BOTTOM OF THE HUB. THERE IS A WHITE SPOT IN THE PHOTO THAT COULD BE RELATED TO THE LIGHTING. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302890, LOT 3198062. 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. 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.
ADDITIONAL INFORMATION RECEIVED. MATERIAL#: 302890, BATCH#: 3198062. IT WAS REPORTED BY THE CUSTOMER THAT EPOXY IN FLUID PATH. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED WE ARE HAVING MORE ISSUES WITH PN 302890, SPECIFICALLY EPOXY IN FLUID PATH. I HAVE ALREADY WRITTEN THE COMPLAINT DEPARTMENT BUT HAVE NOT RECEIVED ANY RESPONSE. COMMENTS ON (B)(6) 2024. I WILL BE SENDING OUT THE SAMPLES THIS WEEK. COMMENTS ON (B)(6) 2024. 1) BATCH NUMBER IS 3198062. 2) SAMPLES HAVE BEEN SENT . 3) WE HAVE SEEN THIS ISSUE SINCE (B)(6) 2023. 5) ISSUE DID NOT INVOLVE A PATIENT OR USER. 6) NO, EVENT HAS NOT INVOLVED LIFE THREATENING SITUATION. 7) WE HAVE HAD A MINIMUM OF 30 INSTANCES FOUND, POSSIBLY MORE.
MATERIAL#: (B)(4). BATCH#: UNKNOWN IT WAS REPORTED BY THE CUSTOMER THAT EPOXY IN FLUID PATH. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED WE ARE HAVING MORE ISSUES WITH PN 302890, SPECIFICALLY EPOXY IN FLUID PATH. I HAVE ALREADY WRITTEN THE COMPLAINT DEPARTMENT BUT HAVE NOT RECEIVED ANY RESPONSE.
NO ADDITIONAL INFORMATION RECEIVED. MATERIAL#: 302890 BATCH#: 3198062. IT WAS REPORTED BY THE CUSTOMER THAT EPOXY IN FLUID PATH. RCC RECEIVED A COMPLAINT VIA EMAIL. WE ARE HAVING MORE ISSUES WITH PN 302890, SPECIFICALLY EPOXY IN FLUID PATH. I HAVE ALREADY WRITTEN THE COMPLAINT DEPARTMENT BUT HAVE NOT RECEIVED ANY RESPONSE. COMMENTS ON 11/02/2024. I WILL BE SENDING OUT THE SAMPLES THIS WEEK. COMMENTS ON 12/04/2024. 1) BATCH NUMBER IS 3198062. 2) SAMPLES HAVE BEEN SENT. 3) WE HAVE SEEN THIS ISSUE SINCE 12/2023. 5) ISSUE DID NOT INVOLVE A PATIENT OR USER. 6) NO, EVENT HAS NOT INVOLVED LIFE THREATENING SITUATION. 7) WE HAVE HAD A MINIMUM OF 30 INSTANCES FOUND, POSSIBLY MORE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 837070 | NEEDLE 30GA 7/8IN BSG CLEAR HUB | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BECTON DICKINSON | 3198062 | 50382903028905 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |