BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
Report
- Report Number
- 1917413-2019-01707
- Event Type
- Malfunction
- Date Received
- July 3, 2019
- Date of Event
- June 13, 2019
- Report Date
- July 17, 2019
- Manufacturer
- BECTON, DICKINSON & CO. (BROKEN BOW)
- Product Code
- JKA
- UDI-DI
- 50382903627610
- PMA / PMN Number
- K911731
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT WAS SENT IN ERROR. ADDITIONAL INFORMATION RECEIVED, CHANGED REPORTABILITY AS NON-REPORTABLE DUE TO "NO VACUUM IN TUBES". NO VACUUM IN TUBES IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION. H3 OTHER TEXT : SEE SECTION H.10.
H.6. OTHER. H.6. SEE SECTION H.10. H3 OTHER TEXT : SEE SECTION H.10.
MATERIAL NO: 362761, BATCH NO: 9003647. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE THE VACUUM WAS INSUFFICIENT AND BLOOD WAS NOT OBTAINED. THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED THEY RECEIVED THE PRODUCT WITH A DEFECTIVE VACCUUM ACTION WITH SOME OF THE TUBES. THE CUSTOMER REPORTED THE BEGING TO USE THE TUBES TO DRAW BLOOD AND THEN FINDS OUT THEY DO NOT WORK."
MATERIAL NO: 362761, BATCH NO: 9003647. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE THE VACUUM WAS INSUFFICIENT AND BLOOD WAS NOT OBTAINED. THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED THEY RECEIVED THE PRODUCT WITH A DEFECTIVE VACCUUM ACTION WITH SOME OF THE TUBES. THE CUSTOMER REPORTED THE BEGING TO USE THE TUBES TO DRAW BLOOD AND THEN FINDS OUT THEY DO NOT WORK."
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
MATERIAL NO: 362761, BATCH NO: 9003647. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE THE VACUUM WAS INSUFFICIENT AND BLOOD WAS NOT OBTAINED. THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED THEY RECEIVED THE PRODUCT WITH A DEFECTIVE VACUUM ACTION WITH SOME OF THE TUBES. THE CUSTOMER REPORTED THE BAGGING TO USE THE TUBES TO DRAW BLOOD AND THEN FINDS OUT THEY DO NOT WORK."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 555221 | BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO. (BROKEN BOW) | 9003647 | 50382903627610 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |