BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE
Report
- Report Number
- 9617032-2023-01461
- Event Type
- Malfunction
- Date Received
- October 13, 2023
- Date of Event
- September 20, 2023
- Report Date
- May 1, 2024
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES, D.9:DEVICE EVAL BY MANUFACTURER? YES, D9: RETURNED TO MANUFACTURER ON: 01-MAY-2024. H.6 INVESTIGATION SUMMARY MATERIAL #: 368838, LOT/BATCH #: 3142293, BD RECEIVED 1 SAMPLE FOR INVESTIGATION. THE SAMPLE WAS EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR BROKEN CANNULA WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND THE ISSUE OF BROKEN CANNULA 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 BROKEN CANNULA. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.
H.6. INVESTIGATION SUMMARY: "MATERIAL #: 368838, LOT/BATCH #: 3142293. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING, EACH USED TO DRAW 6 VACUTAINER TUBES, AND NO ISSUES WERE OBSERVED RELATING TO CANNULA BREAKS OFF AS ALL SAMPLES MET SPECIFICATIONS. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE CANNULA BREAKS OFF. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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 THAT DURING USAGE OF BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE TEH CANNULA BREAKS OFF OR PULLS OUT. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: THE NEEDLE BROKE OFF IN THE ARTERIAL LINE SAMPLING PAD. THE HEMODIALYSIS DEPARTMENT HAS INFORMED ME OF AN INCIDENT INVOLVING THE USE OF A 22G ECLIPSE BLACK SAFETY NEEDLE REF368838 ON A DIALYSIS LINE. DURING SAMPLING, THE NEEDLE BROKE OFF IN THE ARTERIAL LINE SAMPLING PAD, SENDING AIR INTO THE EXTRACORPOREAL CIRCUIT DURING DIALYSIS. THE SESSION WAS STOPPED IN ORDER TO REASSEMBLE A CIRCUIT ON ANOTHER DIALYSIS MACHINE.
IT WAS REPORTED THAT DURING USAGE OF BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE TEH CANNULA BREAKS OFF OR PULLS OUT. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: THE NEEDLE BROKE OFF IN THE ARTERIAL LINE SAMPLING PAD. THE HEMODIALYSIS DEPARTMENT HAS INFORMED ME OF AN INCIDENT INVOLVING THE USE OF A 22G ECLIPSE BLACK SAFETY NEEDLE REF368838 ON A DIALYSIS LINE. DURING SAMPLING, THE NEEDLE BROKE OFF IN THE ARTERIAL LINE SAMPLING PAD, SENDING AIR INTO THE EXTRACORPOREAL CIRCUIT DURING DIALYSIS. THE SESSION WAS STOPPED IN ORDER TO REASSEMBLE A CIRCUIT ON ANOTHER DIALYSIS MACHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1717025 | BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | 3142293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |