BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
Report
- Report Number
- 9617032-2022-00299
- Event Type
- Malfunction
- Date Received
- April 6, 2022
- Date of Event
- March 24, 2022
- Report Date
- June 1, 2022
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- PMA / PMN Number
- BK050036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR OIL GEL GLOBULES AND GEL SMEARING COULD NOT BE CONFIRMED. FIRST PHOTOGRAPH SHOWS THE INSIDE OF THE USED TUBE. UNABLE TO SEE OIL GEL GLOBULES OR GEL SMEARING FROM THIS ANGLE. SECOND PICTURE SHOWS UNUSED TUBE. THEREFORE UNABLE TO CONFIRM DEFECTS BASED ON THE PHOTOGRAPHS. ADDITIONALLY, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED. 4 RETAINED TUBES WERE, DRAWN WITH HORSE BLOOD, MIXED, STOOD AT ROOM TEMPERATURE FOR 30 MINUTES, BEFORE BEING CENTRIFUGED AT 1300G FOR 10 MINUTES, USING AN MSE MISTRAL 1000 CENTRIFUGE. THE SUPERNATANTS WERE THEN DECANTED AND EXAMINED UNDER MAGNIFICATION FOR ANY SIGNS OF GEL GLOBULES AND GEL SMEARING. NONE WERE FOUND. 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 OIL GEL GLOBULES AND GEL SMEARING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 23-MAY-2022. H6: INVESTIGATION SUMMARY: BD RECEIVED 5 SAMPLES AND 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR OIL GEL GLOBULES AND GEL SMEARING COULD NOT BE CONFIRMED. FIRST PHOTOGRAPH SHOWS THE INSIDE OF THE USED TUBE. UNABLE TO SEE OIL GEL GLOBULES OR GEL SMEARING FROM THIS ANGLE. SECOND PICTURE SHOWS UNUSED TUBE. THEREFORE UNABLE TO CONFIRM DEFECTS BASED ON THE PHOTOGRAPHS ATTACHED. ADDITIONALLY, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED. 4 RETURNED AND RETAINED TUBES WERE, DRAWN WITH HORSE BLOOD, MIXED, STOOD AT ROOM TEMPERATURE FOR 30 MINUTES, BEFORE BEING CENTRIFUGED AT 1300G FOR 10 MINUTES, USING AN MSE MISTRAL 1000 CENTRIFUGE. THE SUPERNATANTS WERE THEN DECANTED AND EXAMINED UNDER MAGNIFICATION FOR ANY SIGNS OF GEL GLOBULES AND GEL SMEARING. NONE WERE FOUND. 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 OIL GEL GLOBULES AND GEL SMEARING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED OIL GEL GLOBULES AND AIR BUBBLES IN THE GEL. THIS EVENT OCCURRED (B)(6) TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: GEL GLOBULES AND GEL ALSO MELTED INSIDE THE GEL TUBES GEL GLOBULES AND GEL ALSO MELTED INSIDE THE GEL TUBES IT'S GETTING STICK IN THE PROBE AND RESULT IN INSTRUMENT BREAKDOWN.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED OIL GEL GLOBULES AND AIR BUBBLES IN THE GEL. THIS EVENT OCCURRED 1000 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: GEL GLOBULES AND GEL ALSO MELTED INSIDE THE GEL TUBES. GEL GLOBULES AND GEL ALSO MELTED INSIDE THE GEL TUBES IT'S GETTING STICK IN THE PROBE AND RESULT IN INSTRUMENT BREAKDOWN.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED OIL GEL GLOBULES AND AIR BUBBLES IN THE GEL. THIS EVENT OCCURRED 1000 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: GEL GLOBULES AND GEL ALSO MELTED INSIDE THE GEL TUBES. GEL GLOBULES AND GEL ALSO MELTED INSIDE THE GEL TUBES IT'S GETTING STICK IN THE PROBE AND RESULT IN INSTRUMENT BREAKDOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2402964 | BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | 1151104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |