BD INTEGRA
Report
- Report Number
- 1213809-2024-00636
- Event Type
- Malfunction
- Date Received
- September 17, 2024
- Date of Event
- August 28, 2024
- Report Date
- December 5, 2024
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- MEG
- UDI-DI
- 30382903052708
- PMA / PMN Number
- K011103
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
PR (B)(4) - SUPPLEMENTAL MDR - FOREIGN MATTER. FOUR PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON PHOTOS EVALUATION, IT WAS OBSERVED THAT A NEEDLE ASSEMBLY WITH NO PLASTIC SHIELD HAS A DROPLET OF EPOXY AT ABOUT THE MIDDLE OF THE NEEDLE. BASED ON THE INVESTIGATION AND WITH THE PHOTO ANALYSIS THE SYMPTOM REPORTED IS CONFIRMED. IT COULD BE POSSIBLE THAT JAM OCCURRED AT THE CANNULATOR INDUCING THE EPOXY DRIP OVER ON THE NEEDLE IN ASSEMBLY LINE. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4082527. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.
MATERIAL# 305270 BATCH# 4082527 IT WAS REPORTED THAT THE BD INTEGRA HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED WENT TO DRAW UP A VACCINATION AND SAW A HARD PLASTIC PIECE STUCK ON THE SYRINGE NEEDLE. ITEM -305270 LOT -4082527.
NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1236227 | BD INTEGRA | SYRINGE, ANTISTICK | MEG | BECTON DICKINSON MEDICAL SYSTEMS | 4082527 | 30382903052708 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |