BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER
Report
- Report Number
- 1024879-2025-00267
- Event Type
- Injury
- Date Received
- March 7, 2025
- Date of Event
- February 3, 2025
- Report Date
- June 19, 2025
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- FMI
- UDI-DI
- 50382903686501
- PMA / PMN Number
- K982541
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY BD HAD NOT RECEIVED ANY SAMPLES OR PHOTOS FOR INVESTIGATION. BD CONDUCTED FUNCTIONAL TESTS ON RETAINED SAMPLES. FOR LOT 4243605, 10 RETAINED SAMPLES UNDERWENT FUNCTIONAL TESTS, AND ALL SAMPLES PASSED AS THERE WERE NO ISSUES WITH SIDE PIERCED SLEEVES, POOR SLEEVE RECOVERY, OR SLEEVE LEAKAGE. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOT 4243605, FOR THE INDICATED FAILURE MODE: SLEEVE FUNCTION. 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 THE IDENTIFICATION OF EMERGING TRENDS.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: INVESTIGATION SUMMARY BD HAD NOT RECEIVED ANY SAMPLES OR PHOTOS FOR INVESTIGATION. BD CONDUCTED FUNCTIONAL TESTS ON RETAINED SAMPLES FROM TWO DIFFERENT LOTS. FOR LOT 4157674, A TOTAL OF 20 RETAINED SAMPLES WERE TESTED FOR PROPER ACTIVATION, AND ALL SAMPLES FUNCTIONED CORRECTLY WITHOUT ANY ISSUES. ADDITIONALLY, FOR LOT 4243605, 10 RETAINED SAMPLES UNDERWENT FUNCTIONAL TESTS, AND ALL SAMPLES PASSED AS THERE WERE NO ISSUES WITH SIDE PIERCED SLEEVES, POOR SLEEVE RECOVERY, OR SLEEVE LEAKAGE. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOT 4157674, FOR THE INDICATED FAILURE MODE: DEFECTIVE LOCKING MECHANISM. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOT 4243605, FOR THE INDICATED FAILURE MODE: SLEEVE FUNCTION. 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 THE IDENTIFICATION OF EMERGING TRENDS.
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, BLOOD WAS LEAKING FROM THE SLEEVE ON THE NON PATIENT END OF TWO (2) DEVICES. ALSO, THE USER RECEIVED A USED NEEDLE STICK INJURY FROM ONE UNIT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. REPORTED VERBATIM: "THE NURSE WHO GOT NSI HAS TESTED BUT NOW TEST RESULTS YET.".
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, BLOOD WAS LEAKING FROM THE SLEEVE ON THE NON PATIENT END OF TWO (2) DEVICES. ALSO, THE USER RECEIVED A USED NEEDLE STICK INJURY FROM ONE UNIT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. REPORTED VERBATIM: "THE NURSE WHO GOT NSI HAS TESTED BUT NOW TEST RESULTS YET.".
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, BLOOD WAS LEAKING FROM THE SLEEVE ON THE NON-PATIENT END OF TWO (2) DEVICES. ALSO, THE USER RECEIVED A USED NEEDLE STICK INJURY FROM ONE UNIT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. REPORTED VERBATIM: "THE NURSE WHO GOT NSI HAS TESTED BUT NOW TEST RESULTS YET."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 863100 | BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON, DICKINSON & CO., (BD) | 4243605 | 50382903686501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |