BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
Report
- Report Number
- 1024879-2021-00906
- Event Type
- Malfunction
- Date Received
- January 6, 2022
- Date of Event
- December 9, 2021
- Report Date
- January 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
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1172583. MEDICAL DEVICE EXPIRATION DATE: 2026-06-30. DEVICE MANUFACTURE DATE: 2021-06-21 . MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN . A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1172583. MEDICAL DEVICE EXPIRATION DATE: 2026-06-30. DEVICE MANUFACTURE DATE: 2021-06-21 . MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN . A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 7 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR SLEEVE LEAKAGE WAS OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT 1172583, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE SLEEVE SLOW RECOVERY AND SLEEVE LEAKAGE. BD DETERMINED THAT THE ROOT CAUSE OF THE INDICATED FAILURE MODE WAS ATTRIBUTED TO INSUFFICIENT LUBRICATION COVERAGE ON NON PATIENT CANNULA CAUSING THE SLEEVE TO NOT FULLY RECOVER.
BASED ON CUSTOMER RESPONSE, THE ONLY BATCH AFFECTED IS # 1172583 THEREFORE THE FOLLOWING THE FOLLOWING IS THE CORRECTED INFORMATION: H.10 FROM: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 1172583 D.4. MEDICAL DEVICE EXPIRATION DATE: 2026-06-30 H.4. DEVICE MANUFACTURE DATE: 2021-06-21 D.4. MEDICAL DEVICE LOT #: UNKNOWN D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H.4. DEVICE MANUFACTURE DATE: UNKNOWN TO: D.4. MEDICAL DEVICE LOT #: 1172583 D.4. MEDICAL DEVICE EXPIRATION DATE: 2026-06-30 H.4. DEVICE MANUFACTURE DATE: 2021-06-21
IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THERE WAS POOR SLEEVE FUNCTION. THE SLEEVE FUNCTION AND LEAKAGE EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "IN SOME BLOOD DRAWS, THE SLEEVE IN THE INNER PART OF THE ADAPTOR DIDN'T RECOVER. WHEN THE TUBE IS REMOVED AND ANOTHER INSERTED, IT STAYS BLEEDING FROM PATIENT." THERE WAS NO REPORT OF EXPOSURE OR MEDICAL INTERVENTIONS.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THERE WAS POOR SLEEVE FUNCTION. THE SLEEVE FUNCTION AND LEAKAGE EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "IN SOME BLOOD DRAWS, THE SLEEVE IN THE INNER PART OF THE ADAPTOR DIDN'T RECOVER. WHEN THE TUBE IS REMOVED AND ANOTHER INSERTED, IT STAYS BLEEDING FROM PATIENT." THERE WAS NO REPORT OF EXPOSURE OR MEDICAL INTERVENTIONS.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THERE WAS POOR SLEEVE FUNCTION. THE SLEEVE FUNCTION AND LEAKAGE EVENT OCCURRED 19 TIMES EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "IN SOME BLOOD DRAWS, THE SLEEVE IN THE INNER PART OF THE ADAPTOR DIDN'T RECOVER. WHEN THE TUBE IS REMOVED AND ANOTHER INSERTED, IT STAYS BLEEDING FROM PATIENT." THERE WAS NO REPORT OF EXPOSURE OR MEDICAL INTERVENTIONS.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THERE WAS POOR SLEEVE FUNCTION. THE SLEEVE FUNCTION AND LEAKAGE EVENT OCCURRED 19 TIMES EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "IN SOME BLOOD DRAWS, THE SLEEVE IN THE INNER PART OF THE ADAPTOR DIDN'T RECOVER. WHEN THE TUBE IS REMOVED AND ANOTHER INSERTED, IT STAYS BLEEDING FROM PATIENT." THERE WAS NO REPORT OF EXPOSURE OR MEDICAL INTERVENTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57412 | BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON, DICKINSON & CO., (BD) | 368607 | 1172583 | 50382903686075 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |