BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE
Report
- Report Number
- 1024879-2020-00475
- Event Type
- Injury
- Date Received
- July 16, 2020
- Date of Event
- June 22, 2020
- Report Date
- August 4, 2020
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- FMI
- UDI-DI
- 50382903686075
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
TYPE OF REPORTABLE EVENTS: SERIOUS INJURY. PRIMARY CARE PHYSICIAN WAS CONSULTED MAKING THIS MDR A SERIOUS INJURY REPORTABLE EVENT.
THE FOLLOWING INFORMATION HAS BEEN UPDATED: B.3. DATE OF EVENT: (B)(6) 2020.
H.6. INVESTIGATION SUMMARY BD RECEIVED 5 SAMPLES FROM THE CUSTOMER FOR INVESTIGATION. ALL SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR SEPARATES WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.
IT WAS REPORTED THAT THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE EXPERIENCED THE NEEDLE AND HOLDER SEPARATING/SPINNING OUT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 368607; BATCH NO. 0003867. A LAB STAFF WAS PREPARING TO PERFORM A VENIPUNCTURE WHEN SHE UNSHEATHED THE VACUTAINER NEEDLE AND THE NEEDLE CAME LOOSE AND DISLODGED IN THE OPPOSITE WRIST. THE CLEAN NEEDLE WAS REMOVED AND FIRST AID WAS APPLIED AND PRIMARY CARE PHYSICIAN WAS CONSULTED.
IT WAS REPORTED THAT THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE EXPERIENCED THE NEEDLE AND HOLDER SEPARATING/SPINNING OUT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 368607 BATCH NO. 0003867. A LAB STAFF WAS PREPARING TO PERFORM A VENIPUNCTURE WHEN SHE UNSHEATHED THE VACUTAINER NEEDLE AND THE NEEDLE CAME LOOSE AND DISLODGED IN THE OPPOSITE WRIST. THE CLEAN NEEDLE WAS REMOVED AND FIRST AID WAS APPLIED AND PRIMARY CARE PHYSICIAN WAS CONSULTED.
IT WAS REPORTED THAT THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE EXPERIENCED THE NEEDLE AND HOLDER SEPARATING/SPINNING OUT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. (B)(6) BATCH NO. 0003867 A LAB STAFF WAS PREPARING TO PERFORM A VENIPUNCTURE WHEN SHE UNSHEATHED THE VACUTAINER NEEDLE AND THE NEEDLE CAME LOOSE AND DISLODGED IN THE OPPOSITE WRIST. THE CLEAN NEEDLE WAS REMOVED AND FIRST AID WAS APPLIED AND PRIMARY CARE PHYSICIAN WAS CONSULTED.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. FDA DEVICE PROBLEM CODE(S): (B)(4), FDA PATIENT PROBLEM CODE(S): (B)(4).
HOLD FOR MARLO 8.6IT WAS REPORTED THAT THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE EXPERIENCED THE NEEDLE AND HOLDER SEPARATING/SPINNING OUT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 368607, BATCH NO. 0003867. A LAB STAFF WAS PREPARING TO PERFORM A VENIPUNCTURE WHEN SHE UNSHEATHED THE VACUTAINER NEEDLE AND THE NEEDLE CAME LOOSE AND DISLODGED IN THE OPPOSITE WRIST. THE CLEAN NEEDLE WAS REMOVED AND FIRST AID WAS APPLIED AND PRIMARY CARE PHYSICIAN WAS CONSULTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 751438 | BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON, DICKINSON & CO., (BD) | 368607 | 0003867 | 50382903686075 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |