BD CONNECTA PLUS3 BLUE
Report
- Report Number
- 9610847-2025-00017
- Event Type
- Malfunction
- Date Received
- February 5, 2025
- Date of Event
- January 16, 2025
- Report Date
- May 9, 2025
- Manufacturer
- BD SUZHOU (MDS)
- Product Code
- FOZ
- UDI-DI
- 00382903946020
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION RESULTS: AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF PRODUCT MALFUNCTION DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
E AND F CODES HAVE BEEN UPDATED TO INSUFFICIENT INFORMATION.
FOLLOW UP MDR FOR CORRECTION. E AND F CODE UPDATED.
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 2 PHOTOS AND 4 PHYSICAL SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF LEAKAGE WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED THAT NO DEFECT WAS FOUND. BD COULD NOT DETERMINE A MANUFACTURING RELATED ROOT CAUSE SINCE THE REPORTED DEFECT WAS NOT CONFIRMED DURING THE EVALUATION OF THE SAMPLE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
NO ADDITIONAL INFORMATION.
NO ADDITIONAL INFORMATION.
IT WAS REPORTED THAT BD CONNECTA PLUS3 BLUE LEAKED. DWH IS LEAKING. WHEN DID THE INCIDENT OCCUR? DURING USE.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64682 | BD CONNECTA PLUS3 BLUE | INTRAVASCULAR CATHETER | FOZ | BD SUZHOU (MDS) | UNKNOWN | 00382903946020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |