BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES
Report
- Report Number
- 9617032-2023-00653
- Event Type
- Malfunction
- Date Received
- June 2, 2023
- Date of Event
- May 4, 2023
- Report Date
- June 13, 2023
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: MATERIAL #: 365049 LOT/BATCH #: 2033806 BD RECEIVED 7 SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING ALONG WITH 13 RETENTION SAMPLES FROM BD INVENTORY AND THE INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. 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 UNDERFILL. 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. H3 OTHER TEXT : SEE H.10.
H.6 INVESTIGATION SUMMARY HAS BEEN UPDATED FROM: BD RECEIVED 7 SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING ALONG WITH 13 RETENTION SAMPLES FROM BD INVENTORY AND THE INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. 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 UNDERFILL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. UPDATED TO: BD DID RECEIVE 7 SAMPLES FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. 7 RETURNED AND 13 RETAINED SAMPLES WERE DRAW-TESTED WITH DEIONIZED WATER. THE WATER IS DRAWN FROM A COMPENSATED DRAW APPARATUS. THIS COMPRISES OF A HEADER TANK, WHICH IS CONNECTED VIA TUBING TO A DIRECT DRAW ADAPTER AT THE END, INTO WHICH THE TUBE IS INSERTED. THE LEVEL AT WHICH THE TUBE IS INSERTED INTO THE APPARATUS, IS DETERMINED BY LOCAL ATMOSPHERIC PRESSURE. THIS SIMULATES THE BLOOD DRAWING METHOD. THEN THE DRAWN TUBES ARE WEIGHED ON A CALIBRATED BALANCE. FROM THIS TESTING IT WAS DETERMINED THAT ALL 20 TUBES DREW WITHIN SPECIFICATION. BD WAS UNABLE TO CONFIRM CUSTOMERS INDICATED FAILURE MODE BASED ON THE RETURNED AND RETAINED SAMPLES TEST RESULTS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER: 2033806 THE ¿AS REPORTED¿ DEFECT CODE. A REVIEW OF RISK MANAGEMENT DOCUMENTATION INDICATES THAT THE POTENTIAL RISK OF THE REPORTED FAILURE MODE WAS APPROPRIATELY ASSESSED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. 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 IDENTIFICATION OF EMERGING TRENDS. ADDED TO IMDRF ANNEX B GRID: B02 FOR DEVICE HISTORY REVIEW.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 2023-05-17. H.6. INVESTIGATION SUMMARY: BD RECEIVED 7 SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING ALONG WITH 13 RETENTION SAMPLES FROM BD INVENTORY AND THE INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. 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 UNDERFILL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES THAT THERE WAS UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO VACUUM, THE PHLEBOTOMIST COMPLAINS THAT ALL THE BARRICOR TUBE SAMPLES ARE EITHER NO VACUUM AS ALL OR THEY SUCK THE BLOOD VERY SLOWLY COMPARING THE SST GEL OR NON GEL TUBES DURING USE.
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES THAT THERE WAS UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO VACUUM, THE PHLEBOTOMIST COMPLAINS THAT ALL THE BARRICOR TUBE SAMPLES ARE EITHER NO VACUUM AS ALL OR THEY SUCK THE BLOOD VERY VERY SLOWLY COMPARING THE SST GEL OR NON GEL TUBES. DURING USE
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES THAT THERE WAS UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:NO VACUUM, THE PHLEBOTOMIST COMPLAINS THAT ALL THE BARRICOR TUBE SAMPLES ARE EITHER NO VACUUM AS ALL OR THEY SUCK THE BLOOD VERY VERY SLOWLY COMPARING THE SST GEL OR NON GEL TUBES.DURING USE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1898246 | BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | 2033806 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |