BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
Report
- Report Number
- 1024879-2022-00352
- Event Type
- Malfunction
- Date Received
- July 12, 2022
- Date of Event
- June 8, 2022
- Report Date
- August 18, 2022
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- FMI
- UDI-DI
- 50382903686075
- PMA / PMN Number
- K982541
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2055983. MEDICAL DEVICE EXPIRATION DATE: 2027-02-28. DEVICE MANUFACTURE DATE: 2022-02-24. MEDICAL DEVICE LOT #: 2090159. MEDICAL DEVICE EXPIRATION DATE: 2027-03-31. DEVICE MANUFACTURE DATE: 2022-03-31. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9. DEVICE AVAILABLE FOR EVALUATION? YES D9. RETURNED TO MANUFACTURER ON: 06/21/2022 H.6. INVESTIGATION SUMMARY MATERIAL #: 368607 LOT/BATCH #: 2055983 & 2090159 BD RECEIVED 5 SHELF CARTONS OF CUSTOMER SAMPLES FOR LOT 2055983 AND 4 SHELF CARTONS OF CUSTOMER SAMPLES FOR LOT 2090159 AS WELL AS 2 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR SLEEVE LEAKAGE WAS OBSERVED. ADDITIONALLY, 20 OF THE CUSTOMER SAMPLES (10 FROM EACH REPORTED LOT) WERE CHOSEN AT RANDOM AND EVALUATED BY FUNCTIONAL TESTING, EACH USED TO DRAW 10 TUBES WITH WATER, AND THE INDICATED FAILURE MODE FOR SLEEVE LEAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE SLEEVE LEAKAGE. BD DETERMINED THAT THE ROOT CAUSE OF THE INDICATED FAILURE MODE WAS ATTRIBUTED TO INSUFFICIENT LUBRICATION COVERAGE ON THE NP CANNULA CAUSING THE SLEEVE TO NOT RECOVER FULLY. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THERE WAS BLOOD LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE AND POOR SLEEVE FUNCTION. THE DEVICE SEPARATION EVENT OCCURRED 15 TIMES. THE SAMPLE LEAKAGE EVENT OCCURRED 1 TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE RUBBER SLEEVE THAT IS PUSHED BACK WHEN A TUBE IS PRESSED ONTO THE NEEDLE HAS NOT BEEN RETRACTING AND COVERING THE NEEDLE WHEN THE TUBES ARE CHANGED. THIS CAUSES THE PATIENT¿S BLOOD TO POUR OUT OF THE NEEDLE, OUT OF THE CUP, AND DOWN THE PATIENT¿S ARM." NO MEDICAL INTERVENTIONS WERE REPORTED.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THERE WAS BLOOD LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE AND POOR SLEEVE FUNCTION. THE DEVICE SEPARATION EVENT OCCURRED 15 TIMES. THE SAMPLE LEAKAGE EVENT OCCURRED 1 TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE RUBBER SLEEVE THAT IS PUSHED BACK WHEN A TUBE IS PRESSED ONTO THE NEEDLE HAS NOT BEEN RETRACTING AND COVERING THE NEEDLE WHEN THE TUBES ARE CHANGED. THIS CAUSES THE PATIENT¿S BLOOD TO POUR OUT OF THE NEEDLE, OUT OF THE CUP, AND DOWN THE PATIENT¿S ARM." NO MEDICAL INTERVENTIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 652735 | BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON, DICKINSON & CO., (BD) | 368607 | SEE H.10 | 50382903686075 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |